Label: 4101 FIRST AID KIT- 4101 first aid kit
4098 FIRST AID KIT- 4098 first aid kit
4099 FIRST AID KIT- 4099 first aid kit
4100 FIRST AID KIT- 4100 first aid kit
4102 FIRST AID KIT- 4102 first aid kit
4097 FIRST AID KIT- 4097 first aid kit
4103 FIRST AID KIT- 4103 first aid kit
4105 FIRST AID KIT- 4105 first aid kit
4106 FIRST AID KIT- 4106 first aid kit
4104 FIRST AID KIT- 4104 first aid kit

  • NDC Code(s): 0498-0730-01, 0498-2001-01, 0498-4097-01, 0498-4098-01, view more
    0498-4099-01, 0498-4100-01, 0498-4101-01, 0498-4102-01, 0498-4103-01, 0498-4104-01, 0498-4105-01, 0498-4106-01
  • Packager: Honeywell Safety Products USA, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 20, 2019

If you are a consumer or patient please visit this version.

  • First Aid Burn Cream Active ingredient

    Benzalkonium chloride o.13%

    Lidocaine HCl 0.5%

    Close
  • First Aid Burn Cream Purpose

    First aid antiseptic

    External analgesic

    Close
  • First Aid Burn Cream Uses

    • prevent skin infection
    • for temporary relief of pain associated with minor burns
    Close
  • First Aid Burn Cream Warnings

    For external use only

    Do not use

    • in or near the eyes
    • if you are allergic to any of the ingredients
    • in large areas of the body, particularly over raw surfaces or blistered areas
    • for more than 10 days


    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occurs again within a few days
    Close
  • First Aid Burn Cream Directions

    • adults and children 2 years of age and older:
    • clean the affected area
    • apply a small amount of this product (equal to the surface area of the tip of a finger) onto affected area 1 to 3 times daily
    • may be covered with a sterile bandage
    • children under 2 years of age: consult a doctor
    Close
  • First Aid Burn Cream Other information

    • tamper evident sealed packets
    • do not use if packet is opened or torn
    Close
  • First Aid Burn Cream Inactive ingredients

    aloe barbadensis juice, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl stearate SE, methylparaben, mineral oil, PEG-100, propylene glycol, propylparaben, stearic acid, trolamine, water

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  • First Aid Burn Cream Questions

    1-800-430-5490

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  • BZK Antiseptic Wipe Active ingredient

    Benzalkonium chloride 0.13%

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  • BZK Purpose

    First aid antiseptic

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  • BZK Uses

    Antiseptic cleansing of face, hands, and body without soap and water

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  • BZK Warnings

    For external use only

    BZK
    Do not use

    • in the eyes or over large areas of the body
    • on mucous membranes
    • on irritated skin
    • in case of deep puncture wounds, animal bites or serious burns, consult a doctor
    • longer than 1 week unless directed by a doctor

    Stop use and ask a doctor if

    • if irritation, redness or other symptoms develop
    • the condition persists or gets worse

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

    Close
  • BZK Directions

    • .tear open packet and use as a washcloth
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  • BZK Other information

    • store at room temperature 15 o to 30 o C (59 o - 86 oF)
    • do not reuse towelette
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  • BZK Inactive ingredients

    water

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  • BZK Questions

    1-800-430-5490

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  • Aypanal Active igredient

    Acetaminophen 325 mg

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  • Aypanal Purpose

    Pain reliever/fever reducer

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  • Aypanal Uses

    • temporarily relieves minor aches and pains due to the common cold and headache
    • temporarily reduces fever

    Ask a doctor before use if you have

    liver disease

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  • Aypanal Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg in 24 hours, which is the maximum daily amount - child takes

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    skin reddening
    blisters
    rash

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    Ask a doctor before use if you have

    liver disease

    Ask a doctor or pharmacist before use if

    you are taking the blood thinning drug warfarin

    if preganat or breast feeding

    ask a health professional before use

    Keep out of rech of children

    Keep out of reach of children

    Overdose Warning

    Overdose warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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  • Aypanal Directions

    • do not take more than directed (see overdose warning) adults and children 12 years of age or older
    • take two tablets every 4-6 hours while symptoms last
    • do not take more than directed (see overdose warning)

    adults and children 12 years of age or older

    • take two tablets every 4-6 hours while symptoms last
    • do not take more than 12 tablets in 24 hours
    • children 6 to under 12 years of age
    • take 1 tablet every 4-6 hours while symptoms last
    • do not take more than 5 tablets in 24 hours
    • children under 6 years
    • consult a doctor
    Close
  • Aypanal Other information

    store at room temperature 15 o to 30 o C (59 o - 86 oF) TAMPER EVIDENT PACKETS- DO NOT USE IF OPEN OR TORN

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  • Aypanal Inactive ingredients

    corn starch, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid.

    Close
  • Aypanal Questions or Comments?

    1-800-430-5490

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  • Sting Relief Active ingredient

    Ethyl alcohol 50.0%

    Lidocaine HCl 2.0%

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  • Sting Relief Purpose

    Antiseptic

    Topical pain relief

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  • Sting Relief Uses

    • prevent infection in minor scrapes, and temporary relief of itching of insect bites
    Close
  • Sting Relief Warnings


    For external use only

    Flammable, keep away from open fire or flame

    Do not use

    • over large areas of the body
    • in eyes
    • over raw or blistered areas

    Stop use and ask a doctor

    • if conditions worsen or persist for more than 7 days or clear up and occur again within a few days

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away

    Close
  • Sting Relief Directions

    • adults and children 2 years and older: Apply to cleaned affected area not more than 3 times daily.
    • children under 2 years of age: consult a doctor.
    Close
  • Sting Relief Inactive ingredients

    benzalkonium chloride, menthol, and purified water

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  • Sting relief Questions or Comments

    1-800-430-5490

    Close
  • Neomycin Antibiotic Ointment Active ingredient

    Neomycin sulfate (5 mg equivalent to 3.5 mg Neomycin base)

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  • Neomycin Antibiotic Ointment Purpose

    First aid antibiotic

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  • Neomycin Antibiotic Ointment Uses

    first aid to help prevent infection in - minor cuts - scrapes - burns

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  • Neomycin Antibiotic Ointment Warnings

    For external use only

    Do not use

    • in the eyes
    • over large areas of the body

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    Stop use and ask a doctor if

    • the condition persists or gets worse
    • a rash or other allergic reaction develops
    • you need to use longer than 1 week

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away

    Close
  • Neomycin Antibiotic Ointment Directions

    • clean the affected area
    • apply a small amount of the product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
    • may be covered with a sterile bandage
    Close
  • Neomycin Antibiotic Ointment Other information

    store at 15 o to 25 oC (59 o to 77 oF)

    Close
  • Neomycin Antibiotic Ointment Inactive ingredient

    petrolatum

    Close
  • Neomycin Antibiotic Ointment Questions

    1-800-430-5490

    Close
  • 4097 019700-0001L Kit Contents

    1 GAUZE PADS, 3" X 3", 4 PER
    1 TWEEZER PLASTICS 4"
    1 FIRST AID GUIDE ASHI
    1 GAUZE CLEAN-WRAP BDGE N/S 2"
    1 GAUZE CLEAN-WRAP BDGE N/S 3"
    1 ABD COMBINE PAD 5" X 9"
    1 BAGGED COMP MISC
    1 SCISSOR BDGE 4" RED PLS HDL
    1 2 PR LRG NITRILE GLVES ZIP BAG
    1 1" X 3" PLASTIC BANDS 16/BAG
    2 TAPE ADHESIVE 1/2 X 2.5 125133
    1 ADH BNDG PLASTIC EX-LG 4"X 2"
    1 KIT, PP 10 UNIT FA
    1TRI BNDG NON WOVEN 40"X40"X56"
    1 COLD PACK UNIT 4"X6" BULK
    1 WOVEN FINGERTIP BANDAGE 2"

    Close
  • 4098 019700-4500F Kit Contents

    1 TWEEZER PLASTICS 4"
    1 IRST AID GUIDE ASHI
    1 GAUZE CLEAN-WRAP BDGE N/S 2"
    1 GAUZE CLEAN-WRAP BDGE N/S 3"
    1 ABD COMBINE PAD 5" X 9"
    1 BAGGED COMP MISC
    1 SCISSOR BDGE 4" RED PLS HDL
    1 2 PR LRG NITRILE GLVES ZIP BAG
    1 1" X 3" PLASTIC BANDS 16/BAG
    2 TAPE ADHESIVE 1/2 X 2.5 125133
    1 ADH BNDG PLASTIC EX-LG 4"X 2"
    1 KIT, PP 10 UNIT FA
    1 TRI BNDG NON WOVEN 40"X40"X56"
    1 COLD PACK UNIT 4"X6" BULK
    4 GAUZE PADS 2"X2" 12PLY
    1 GAUZE PADS 3"X3" 12PLY
    1 WOVEN FINGERTIP BANDAGE 2"

    Close
  • 4099 Z019850 Kit Contents

    1 TWEEZER PLASTICS 4"
    1 GAUZE CLEAN-WRAP BDGE N/S 3"
    1 ABD COMBINE PAD 5" X 9"
    1 BAGGED COMP MISC
    1 SCISSOR BDGE 4" RED PLS HDL
    1 2 PR LRG NITRILE GLVES ZIP BAG
    1 1" X 3" PLASTIC BANDS 16/BAG
    1 TAPE ADHESIVE 1/2 X 2.5 125133
    1 KIT, PP 10 UNIT FA
    1 TRI BNDG NON WOVEN 40"X40"X56"
    1 COLD PACK UNIT 4"X6" BULK
    1 EYE PADS STD OVAL STERILE
    4 GAUZE PADS 3"X3" 12PLY

    Close
  • 4100 Z019743-0030L Kit Contents

    1 TWEEZER PLASTICS 4"
    2 GAUZE CLEAN-WRAP BDGE N/S 3"
    1 ABD COMBINE PAD 5" X 9"
    1 BAGGED COMP MISC
    1 SCISSOR BDGE 4" RED PLS HDL
    1 2 PR LRG NITRILE GLVES ZIP BAG
    2 1" X 3" PLASTIC BANDS 16/BAG
    1 TAPE ADHESIVE 1/2 X 2.5 125133
    1 KIT, PP 16 UNIT FA
    1 TRI BNDG NON WOVEN 40"X40"X56"
    1 COLD PACK UNIT 4"X6" BULK
    1 EYE PADS STD OVAL STERILE
    6 GAUZE PADS 3"X3" 12PLY

    Close
  • 4101 Z019759-0035L Kit Contents

    1 GAUZE PADS, 3" X 3", 4 PER
    1 ADHESIVE BDG,PLSTIC,1"X3"16PER
    FLEXICON 2"X 4.1 YD 12/BAG
    1 FIRST AID GUIDE ASHI
    1 ABD COMBINE PAD 5" X 9"
    2 BUGX TOWELETTE, BULK, 300/CS
    1 BAGGED COMP MISC
    1 SCISSOR BDGE 4" RED PLS HDL
    1 2 PR LRG NITRILE GLVES ZIP BAG
    1 TAPE ADHESIVE 1/2 X 2.5 125133
    1 KIT STL 10 UN WHITE 01

    Close
  • 4102 Z019742-0029L Kit Contents

    1 TWEEZER PLASTICS 4"
    1 GAUZE CLEAN-WRAP BDGE N/S 3"
    1 ABD COMBINE PAD 5" X 9"
    1 BAGGED COMP MISC
    1 1 SCISSOR BDGE 4" RED PLS HDL
    2 PR LRG NITRILE GLVES ZIP BAG
    1 1" X 3" PLASTIC BANDS 16/BAG
    1 TAPE ADHESIVE 1/2 X 2.5 125133
    1 KIT, PP 10 UNIT FA
    1 TRI BNDG NON WOVEN 40"X40"X56"
    1 COLD PACK UNIT 4"X6" BULK
    1 EYE PADS STD OVAL STERILE
    1 GAUZE PADS 3"X3" 12PLY

    Close
  • 4103 Z019701-0001L Kit Contents

    1 TWEEZER PLASTICS 4"
    1 FIRST AID GUIDE ASHI
    1 GAUZE CLEAN-WRAP BDGE N/S 2"
    1 GAUZE CLEAN-WRAP BDGE N/S 3"
    1 ABD COMBINE PAD 5" X 9"
    1 BAGGED COMP MISC
    1 SCISSOR BDGE 4" RED PLS HDL
    1 2 PR LRG NITRILE GLVES ZIP BAG
    1 1" X 3" PLASTIC BANDS 16/BAG
    2 TAPE ADHESIVE 1/2 X 2.5 125133
    1 ADH BNDG PLASTIC EX-LG 4"X 2"
    1 KIT STL 10 UN WHITE 01
    1 TRI BNDG NON WOVEN 40"X40"X56"
    1 COLD PACK UNIT 4"X6" BULK
    4 GAUZE PADS 2"X2" 12PLY
    4 GAUZE PADS 3"X3" 12PLY
    1 WOVEN FINGERTIP BANDAGE 2"

    Close
  • 4104 Z019700-0001L Kit Contents

    1 TWEEZER PLASTICS 4"
    1 FIRST AID GUIDE ASHI
    1 GAUZE CLEAN-WRAP BDGE N/S 2"
    1 GAUZE CLEAN-WRAP BDGE N/S 3"
    1 ABD COMBINE PAD 5" X 9"
    1 BAGGED COMP MISC
    1 SCISSOR BDGE 4" RED PLS HDL
    1 2 PR LRG NITRILE GLVES ZIP BAG
    1 1" X 3" PLASTIC BANDS 16/BAG
    2 TAPE ADHESIVE 1/2 X 2.5 125133
    1 ADH BNDG PLASTIC EX-LG 4"X 2"
    1 KIT, PP 10 UNIT FA
    1 TRI BNDG NON WOVEN 40"X40"X56"
    1 COLD PACK UNIT 4"X6" BULK
    1 GAUZE PADS 2"X2" 12PLY
    4 GAUZE PADS 3"X3" 12PLY
    1 WOVEN FINGERTIP BANDAGE 2"

    Close
  • 4105 SF00004715 Kit Contents


    1 TWEEZER PLASTICS 4"
    1 FIRST AID GUIDE ASHI
    2 GAUZE CLEAN-WRAP BDGE N/S 2"
    1 GAUZE CLEAN-WRAP BDGE N/S 3"
    1 ABD COMBINE PAD 5" X 9"
    1 CPR FILTERSHIELD 77-100
    1 BAGGED COMP MISC
    1 SCISSOR BDGE 4" RED PLS HDL
    1 2 PR LRG NITRILE GLVES ZIP BAG
    2 1" X 3" PLASTIC BANDS 16/BAG
    2 TAPE ADHESIVE 1/2 X 2.5 125133
    1 ADH BNDG PLASTIC EX-LG 4"X 2"
    1 KIT, PP 16 UNIT FA
    1 TRI BNDG NON WOVEN 40"X40"X56"
    1 COLD PACK UNIT 4"X6" BULK
    4 GAUZE PADS 2"X2" 12PLY
    1 EYE PADS STD OVAL STERILE
    1 GAUZE PADS 3"X3" 12PLY
    3 WOVEN FINGERTIP BANDAGE 2"
    2 WOVEN KNUCKLE BANDAGE
    1 1 OZ. EYEWASH

    Close
  • 4106 019742-0029L Kit Contents

    1 TWEEZER PLASTICS 4"
    1 GAUZE CLEAN-WRAP BDGE N/S 3"
    1 ABD COMBINE PAD 5" X 9"
    1 BAGGED COMP MISC
    1 SCISSOR BDGE 4" RED PLS HDL
    1 2 PR LRG NITRILE GLVES ZIP BAG
    1 1" X 3" PLASTIC BANDS 16/BAG
    1 TAPE ADHESIVE 1/2 X 2.5 125133
    1 KIT, PP 10 UNIT FA
    1 TRI BNDG NON WOVEN 40"X40"X56"
    1 COLD PACK UNIT 4"X6" BULK
    1 EYE PADS STD OVAL STERILE
    4 GAUZE PADS 3"X3" 12PLY

    Close
  • First Aid Burn Cream Principal Display Panel
  • BZK Principal Display Panel
  • Aypanal Principal Display Panel
  • Sting Relief Principal Display Panel
  • Neomycin Antibiotic Ointment Principal Display Panel
  • 4097 Kit Label 019700-0001L
  • 4098 Kit Label 019700-4500F
  • 4099 Kit Label Z019850
  • 4100 Kit Lael Z019743-0030L
  • 4101 Kit Label Z019759-0035L
  • 4102 Kit Label Z019742-0029L
  • 4103 Kit Label Z019701-0001L
  • 4104 Kit Label Z019700-0001L
  • 4105 Kit Label SF00004715
  • 4106 Kit Label 019742-0029L
  • INGREDIENTS AND APPEARANCE
    4101 FIRST AID KIT 
    4101 first aid kit kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4101
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-4101-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 3 PACKET
    Part 2 6 POUCH 2.4 mL
    Part 3 10 PACKET 9 g
    Part 4 10 PACKET 9 g
    Part 5 10 PACKET 14 mL
    Part 1 of 5
    AYPANAL NON-ASPIRIN 
    acetaminophen tablet
    Product Information
    Item Code (Source) NDC:0498-2001
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    Color white Score 2 pieces
    Shape ROUND Size 10mm
    Flavor Imprint Code circle;U
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-2001-01 2 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 04/10/2012
    Part 2 of 5
    STING RELIEF PAD 
    ethyl alcohol, lidocaine swab
    Product Information
    Item Code (Source) NDC:0498-0733
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.5 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.4 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 12/23/2017
    Part 3 of 5
    FIRST AID BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Item Code (Source) NDC:0498-0903
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 0.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 12/20/2017
    Part 4 of 5
    NEOMYCIN 
    antibiotic ointment
    Product Information
    Item Code (Source) NDC:0498-0730
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0730-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 03/31/2010
    Part 5 of 5
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Item Code (Source) NDC:0498-0501
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 1.4 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 12/21/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/18/2018
    4098 FIRST AID KIT 
    4098 first aid kit kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4098
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-4098-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 3 PACKET
    Part 2 6 POUCH 2.4 mL
    Part 3 10 PACKET 9 g
    Part 4 10 PACKET 9 g
    Part 5 10 PACKET 14 mL
    Part 1 of 5
    AYPANAL NON-ASPIRIN 
    acetaminophen tablet
    Product Information
    Item Code (Source) NDC:0498-2001
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    Color white Score 2 pieces
    Shape ROUND Size 10mm
    Flavor Imprint Code circle;U
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-2001-01 2 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 04/10/2012
    Part 2 of 5
    STING RELIEF PAD 
    ethyl alcohol, lidocaine swab
    Product Information
    Item Code (Source) NDC:0498-0733
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.5 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.4 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 12/23/2017
    Part 3 of 5
    FIRST AID BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Item Code (Source) NDC:0498-0903
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 0.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 12/20/2017
    Part 4 of 5
    NEOMYCIN 
    antibiotic ointment
    Product Information
    Item Code (Source) NDC:0498-0730
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0730-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 03/31/2010
    Part 5 of 5
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Item Code (Source) NDC:0498-0501
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 1.4 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 12/21/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/18/2018
    4099 FIRST AID KIT 
    4099 first aid kit kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4099
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-4099-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 3 PACKET
    Part 2 6 POUCH 2.4 mL
    Part 3 10 PACKET 9 g
    Part 4 10 PACKET 9 g
    Part 5 10 PACKET 14 mL
    Part 1 of 5
    AYPANAL NON-ASPIRIN 
    acetaminophen tablet
    Product Information
    Item Code (Source) NDC:0498-2001
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    Color white Score 2 pieces
    Shape ROUND Size 10mm
    Flavor Imprint Code circle;U
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-2001-01 2 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 04/10/2012
    Part 2 of 5
    STING RELIEF PAD 
    ethyl alcohol, lidocaine swab
    Product Information
    Item Code (Source) NDC:0498-0733
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.5 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.4 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 12/23/2017
    Part 3 of 5
    FIRST AID BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Item Code (Source) NDC:0498-0903
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 0.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 12/20/2017
    Part 4 of 5
    NEOMYCIN 
    antibiotic ointment
    Product Information
    Item Code (Source) NDC:0498-0730
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0730-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 03/31/2010
    Part 5 of 5
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Item Code (Source) NDC:0498-0501
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 1.4 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 12/21/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/18/2018
    4100 FIRST AID KIT 
    4100 first aid kit kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4100
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-4100-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 3 PACKET
    Part 2 6 POUCH 2.4 mL
    Part 3 10 PACKET 9 g
    Part 4 10 PACKET 9 g
    Part 5 10 PACKET 14 mL
    Part 1 of 5
    AYPANAL NON-ASPIRIN 
    acetaminophen tablet
    Product Information
    Item Code (Source) NDC:0498-2001
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    Color white Score 2 pieces
    Shape ROUND Size 10mm
    Flavor Imprint Code circle;U
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-2001-01 2 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 04/10/2012
    Part 2 of 5
    STING RELIEF PAD 
    ethyl alcohol, lidocaine swab
    Product Information
    Item Code (Source) NDC:0498-0733
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.5 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.4 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 12/23/2017
    Part 3 of 5
    FIRST AID BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Item Code (Source) NDC:0498-0903
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 0.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 12/20/2017
    Part 4 of 5
    NEOMYCIN 
    antibiotic ointment
    Product Information
    Item Code (Source) NDC:0498-0730
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0730-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 03/31/2010
    Part 5 of 5
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Item Code (Source) NDC:0498-0501
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 1.4 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 12/21/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/18/2018
    4102 FIRST AID KIT 
    4102 first aid kit kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4102
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-4102-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 3 PACKET
    Part 2 6 POUCH 2.4 mL
    Part 3 10 PACKET 9 g
    Part 4 10 PACKET 9 g
    Part 5 10 PACKET 14 mL
    Part 1 of 5
    AYPANAL NON-ASPIRIN 
    acetaminophen tablet
    Product Information
    Item Code (Source) NDC:0498-2001
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    Color white Score 2 pieces
    Shape ROUND Size 10mm
    Flavor Imprint Code circle;U
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-2001-01 2 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 04/10/2012
    Part 2 of 5
    STING RELIEF PAD 
    ethyl alcohol, lidocaine swab
    Product Information
    Item Code (Source) NDC:0498-0733
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.5 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.4 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 12/23/2017
    Part 3 of 5
    FIRST AID BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Item Code (Source) NDC:0498-0903
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 0.5 g  in 100 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 12/20/2017
    Part 4 of 5
    NEOMYCIN 
    antibiotic ointment
    Product Information
    Item Code (Source) NDC:0498-0730
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0730-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 03/31/2010
    Part 5 of 5
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Item Code (Source) NDC:0498-0501
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 1.4 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 12/21/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/18/2018
    4097 FIRST AID KIT 
    4097 first aid kit kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4097
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-4097-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 3 PACKET
    Part 2 6 POUCH 2.4 mL
    Part 3 10 PACKET 9 g
    Part 4 10 PACKET 9 g
    Part 5 10 PACKET 14 mL
    Part 1 of 5
    AYPANAL NON-ASPIRIN 
    acetaminophen tablet
    Product Information
    Item Code (Source) NDC:0498-2001
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    Color white Score 2 pieces
    Shape ROUND Size 10mm
    Flavor Imprint Code circle;U
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-2001-01 2 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 04/10/2012
    Part 2 of 5
    STING RELIEF PAD 
    ethyl alcohol, lidocaine swab
    Product Information
    Item Code (Source) NDC:0498-0733
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.5 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.4 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 12/23/2017
    Part 3 of 5
    FIRST AID BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Item Code (Source) NDC:0498-0903
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 0.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 12/20/2017
    Part 4 of 5
    NEOMYCIN 
    antibiotic ointment
    Product Information
    Item Code (Source) NDC:0498-0730
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0730-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 03/31/2010
    Part 5 of 5
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Item Code (Source) NDC:0498-0501
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 1.4 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 12/21/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/18/2018
    4103 FIRST AID KIT 
    4103 first aid kit kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4103
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-4103-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 3 PACKET
    Part 2 6 POUCH 2.4 mL
    Part 3 10 PACKET 9 g
    Part 4 10 PACKET 9 g
    Part 5 10 PACKET 14 mL
    Part 1 of 5
    AYPANAL NON-ASPIRIN 
    acetaminophen tablet
    Product Information
    Item Code (Source) NDC:0498-2001
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    Color white Score 2 pieces
    Shape ROUND Size 10mm
    Flavor Imprint Code circle;U
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-2001-01 2 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 04/10/2012
    Part 2 of 5
    STING RELIEF PAD 
    ethyl alcohol, lidocaine swab
    Product Information
    Item Code (Source) NDC:0498-0733
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.5 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.4 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 12/23/2017
    Part 3 of 5
    FIRST AID BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Item Code (Source) NDC:0498-0903
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 0.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 12/20/2017
    Part 4 of 5
    NEOMYCIN 
    antibiotic ointment
    Product Information
    Item Code (Source) NDC:0498-0730
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0730-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 03/31/2010
    Part 5 of 5
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Item Code (Source) NDC:0498-0501
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 1.4 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 12/21/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/18/2018
    4105 FIRST AID KIT 
    4105 first aid kit kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4105
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-4105-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 3 PACKET
    Part 2 6 POUCH 2.4 mL
    Part 3 10 PACKET 9 g
    Part 4 10 PACKET 9 g
    Part 5 10 PACKET 14 mL
    Part 1 of 5
    AYPANAL NON-ASPIRIN 
    acetaminophen tablet
    Product Information
    Item Code (Source) NDC:0498-2001
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    Color white Score 2 pieces
    Shape ROUND Size 10mm
    Flavor Imprint Code circle;U
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-2001-01 2 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 04/10/2012
    Part 2 of 5
    STING RELIEF PAD 
    ethyl alcohol, lidocaine swab
    Product Information
    Item Code (Source) NDC:0498-0733
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.5 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.4 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 12/23/2017
    Part 3 of 5
    FIRST AID BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Item Code (Source) NDC:0498-0903
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 0.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 12/20/2017
    Part 4 of 5
    NEOMYCIN 
    antibiotic ointment
    Product Information
    Item Code (Source) NDC:0498-0730
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0730-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 03/31/2010
    Part 5 of 5
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Item Code (Source) NDC:0498-0501
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 1.4 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 12/21/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/18/2018
    4106 FIRST AID KIT 
    4106 first aid kit kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4106
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-4106-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 3 PACKET
    Part 2 6 POUCH 2.4 mL
    Part 3 10 PACKET 9 g
    Part 4 10 PACKET 9 g
    Part 5 10 PACKET 14 mL
    Part 1 of 5
    AYPANAL NON-ASPIRIN 
    acetaminophen tablet
    Product Information
    Item Code (Source) NDC:0498-2001
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    Color white Score 2 pieces
    Shape ROUND Size 10mm
    Flavor Imprint Code circle;U
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-2001-01 2 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 04/10/2012
    Part 2 of 5
    STING RELIEF PAD 
    ethyl alcohol, lidocaine swab
    Product Information
    Item Code (Source) NDC:0498-0733
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.5 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.4 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 12/23/2017
    Part 3 of 5
    FIRST AID BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Item Code (Source) NDC:0498-0903
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 0.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 12/20/2017
    Part 4 of 5
    NEOMYCIN 
    antibiotic ointment
    Product Information
    Item Code (Source) NDC:0498-0730
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0730-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 03/31/2010
    Part 5 of 5
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Item Code (Source) NDC:0498-0501
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 1.4 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 12/21/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/18/2018
    4104 FIRST AID KIT 
    4104 first aid kit kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4104
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-4104-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 3 PACKET
    Part 2 6 POUCH 2.4 mL
    Part 3 10 PACKET 9 g
    Part 4 10 PACKET 9 g
    Part 5 10 PACKET 14 mL
    Part 1 of 5
    AYPANAL NON-ASPIRIN 
    acetaminophen tablet
    Product Information
    Item Code (Source) NDC:0498-2001
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    Color white Score 2 pieces
    Shape ROUND Size 10mm
    Flavor Imprint Code circle;U
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-2001-01 2 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 04/10/2012
    Part 2 of 5
    STING RELIEF PAD 
    ethyl alcohol, lidocaine swab
    Product Information
    Item Code (Source) NDC:0498-0733
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.5 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.4 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 12/23/2017
    Part 3 of 5
    FIRST AID BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Item Code (Source) NDC:0498-0903
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 0.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 12/20/2017
    Part 4 of 5
    NEOMYCIN 
    antibiotic ointment
    Product Information
    Item Code (Source) NDC:0498-0730
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0730-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 03/31/2010
    Part 5 of 5
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Item Code (Source) NDC:0498-0501
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 1.4 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 12/21/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/18/2018
    Labeler - Honeywell Safety Products USA, INC (079287321)
    Establishment
    Name Address ID/FEI Business Operations
    Honeywell Safety Products USA, INC 079287321 pack(0498-4097, 0498-4098, 0498-4099, 0498-4100, 0498-4101, 0498-4102, 0498-4103, 0498-4104, 0498-4105, 0498-4106)
    Establishment
    Name Address ID/FEI Business Operations
    Ultra Seal Corporation 085752004 manufacture(0498-2001)
    Establishment
    Name Address ID/FEI Business Operations
    Water-Jel Technologies 155522589 manufacture(0498-0903, 0498-0730)
    Establishment
    Name Address ID/FEI Business Operations
    Changzhou Maokang Medical 421317073 manufacture(0498-0501)
    Establishment
    Name Address ID/FEI Business Operations
    Safetec of America Inc 874965262 manufacture(0498-0733)
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