Label: 4107 FIRST AID KIT kit
4108 FIRST AID KIT kit
4109 FIRST AID KIT kit
4110 FIRST AID KIT kit
4111 FIRST AID KIT kit
4119 FIRST AID KIT kit
4120 FIRST AID KIT kit

  • NDC Code(s): 0498-0730-01, 0498-2001-01, 0498-4107-01, 0498-4108-01, view more
    0498-4109-01, 0498-4110-01, 0498-4111-01, 0498-4119-01, 0498-4120-01
  • 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 October 18, 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%

  • First Aid Burn Cream Purpose

    First aid antiseptic

    External analgesic

  • First Aid Burn Cream Uses

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

    • tamper evident sealed packets
    • do not use if packet is opened or torn
  • 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

  • First Aid Burn Cream Questions

    1-800-430-5490

  • BZK Antiseptic Wipe Active ingredient

    Benzalkonium chloride 0.13%

  • BZK Purpose

    First aid antiseptic

  • BZK Uses

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

  • 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.

  • BZK Directions

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

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

    water

  • BZK Questions

    1-800-430-5490

  • Aypanal Active igredient

    Acetaminophen 325 mg

  • Aypanal Purpose

    Pain reliever/fever reducer

  • 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

  • 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.

  • 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
  • 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

  • Aypanal Inactive ingredients

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

  • Aypanal Questions or Comments?

    1-800-430-5490

  • Sting Relief Active ingredient

    Ethyl alcohol 50.0%

    Lidocaine HCl 2.0%

  • Sting Relief Purpose

    Antiseptic

    Topical pain relief

  • Sting Relief Uses

    • prevent infection in minor scrapes, and temporary relief of itching of insect bites
  • 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

  • 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.
  • Sting Relief Inactive ingredients

    benzalkonium chloride, menthol, and purified water

  • Sting relief Questions or Comments

    1-800-430-5490

  • Neomycin Antibiotic Ointment Active ingredient

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

  • Neomycin Antibiotic Ointment Purpose

    First aid antibiotic

  • Neomycin Antibiotic Ointment Uses

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

  • 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

  • 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
  • Neomycin Antibiotic Ointment Other information

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

  • Neomycin Antibiotic Ointment Inactive ingredient

    petrolatum

  • Neomycin Antibiotic Ointment Questions

    1-800-430-5490

  • 4107 019701-0001L 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"

  • 4108 019743-0030L 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
    3 EYE PADS STD OVAL STERILE
    6 GAUZE PADS 3"X3" 12PLY

  • 4109 019759-0035L Kit Contents

    1 GAUZE PADS, 3" X 3", 4 PER
    1 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 1" X 3" PLASTIC BANDS 16/BAG
    1 TAPE ADHESIVE 1/2 X 2.5 125133
    1 KIT STL 10 UN WHITE 01

  • 4110 019760-0036L Kit Contents

    1 FNGRTIP-5 PER, KNCKL BDG-4 PER
    1 GAUZE PADS, 3" X 3", 4 PER
    1 FLEXICON 2"X 4.1 YD 12/BAG
    1 FIRST AID GUIDE ASHI
    1 EMERGENCY SURVIVAL BLANKET
    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 1" X 3" PLASTIC BANDS 16/BAG
    1 TAPE ADHESIVE 1/2 X 2.5 125133
    1 KIT STL 16 UN (HORIZONTAL)
    1 TRI BNDG NON WOVEN 40"X40"X56"

  • 4111 SF00001231 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 BAG ZIPPER POLY 6 X 6 2 MIL
    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"

  • 4119 Z019842 Kit Contents

    1 GAUZE PADS, 3" X 3", 4 PER
    1 ADHESIVE BDG,PLSTIC,1"X3"16PER
    1 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 LABEL COVER, GRAINGER Z019842
    1 TAPE ADHESIVE 1/2 X 2.5 125133
    1 KIT STL 10 UN WHITE 01

  • 4120 Z019760-0036L Kit Contents

    1 FNGRTIP-5 PER, KNCKL BDG-4 PER
    1 GAUZE PADS, 3" X 3", 4 PER
    1 ADHESIVE BDG,PLSTIC,1"X3"16PER
    1 FLEXICON 2"X 4.1 YD 12/BAG
    1 FIRST AID GUIDE ASHI
    1 EMERGENCY SURVIVAL BLANKET
    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 16 UN (HORIZONTAL)
    1 LABEL, VEHICLE KIT (6 Person)

  • First Aid Burn Cream Principal Display Panel

    First Aid Burn Cream

  • BZK Principal Display Panel

    BZK Antiseptic Wipe

  • Aypanal Principal Display Panel

    Aypanal

  • Sting Relief Principal Display Panel

    Sting relief

  • Neomycin Antibiotic Ointment Principal Display Panel

    Neomycin

  • 4107 Kit Label 019701-0029L

    4107 label

  • 4108 Kit Label 019743-0030L

    4108 label

  • 4109 Kit Label 019759-0035L

    4109 label

  • 4110 Kit Lael 019760-0036L

    4110 label

  • 4111 Kit Label SF00001231

    4111 label

  • 4119 Kit Label Z019842

    4119 label

  • 4120 Kit Label Z019760-0036L

    4120 label

  • INGREDIENTS AND APPEARANCE
    4107 FIRST AID KIT 
    4107 first aid kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4107
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4107-011 in 1 KIT; Type 0: Not a Combination Product10/18/201810/18/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 13 PACKET
    Part 26 POUCH 2.4 mL
    Part 310 PACKET 9 g
    Part 410 PACKET 9 g
    Part 510 PACKET 14 mL
    Part 1 of 5
    AYPANAL NON-ASPIRIN 
    acetaminophen tablet
    Product Information
    Item Code (Source)NDC:0498-2001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize10mm
    FlavorImprint Code circle;U
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-2001-012 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/10/2012
    Part 2 of 5
    STING RELIEF PAD 
    ethyl alcohol, lidocaine swab
    Product Information
    Item Code (Source)NDC:0498-0733
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.5 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    10.4 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/23/2017
    Part 3 of 5
    FIRST AID BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Item Code (Source)NDC:0498-0903
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/20/2017
    Part 4 of 5
    NEOMYCIN 
    antibiotic ointment
    Product Information
    Item Code (Source)NDC:0498-0730
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0730-010.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B03/31/2010
    Part 5 of 5
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Item Code (Source)NDC:0498-0501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11.4 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/21/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/18/201810/18/2019
    4108 FIRST AID KIT 
    4108 first aid kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4108
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4108-011 in 1 KIT; Type 0: Not a Combination Product10/18/201810/18/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 13 PACKET
    Part 26 POUCH 2.4 mL
    Part 310 PACKET 9 g
    Part 410 PACKET 9 g
    Part 510 PACKET 14 mL
    Part 1 of 5
    AYPANAL NON-ASPIRIN 
    acetaminophen tablet
    Product Information
    Item Code (Source)NDC:0498-2001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize10mm
    FlavorImprint Code circle;U
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-2001-012 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/10/2012
    Part 2 of 5
    STING RELIEF PAD 
    ethyl alcohol, lidocaine swab
    Product Information
    Item Code (Source)NDC:0498-0733
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.5 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    10.4 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/23/2017
    Part 3 of 5
    FIRST AID BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Item Code (Source)NDC:0498-0903
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/20/2017
    Part 4 of 5
    NEOMYCIN 
    antibiotic ointment
    Product Information
    Item Code (Source)NDC:0498-0730
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0730-010.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B03/31/2010
    Part 5 of 5
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Item Code (Source)NDC:0498-0501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11.4 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/21/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/18/201810/18/2019
    4109 FIRST AID KIT 
    4109 first aid kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4109
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4109-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 13 PACKET
    Part 26 POUCH 2.4 mL
    Part 310 PACKET 9 g
    Part 410 PACKET 9 g
    Part 510 PACKET 14 mL
    Part 1 of 5
    AYPANAL NON-ASPIRIN 
    acetaminophen tablet
    Product Information
    Item Code (Source)NDC:0498-2001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize10mm
    FlavorImprint Code circle;U
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-2001-012 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/10/2012
    Part 2 of 5
    STING RELIEF PAD 
    ethyl alcohol, lidocaine swab
    Product Information
    Item Code (Source)NDC:0498-0733
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.5 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    10.4 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/23/2017
    Part 3 of 5
    FIRST AID BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Item Code (Source)NDC:0498-0903
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/20/2017
    Part 4 of 5
    NEOMYCIN 
    antibiotic ointment
    Product Information
    Item Code (Source)NDC:0498-0730
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0730-010.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B03/31/2010
    Part 5 of 5
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Item Code (Source)NDC:0498-0501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11.4 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/21/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/18/2018
    4110 FIRST AID KIT 
    4110 first aid kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4110
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4110-011 in 1 KIT; Type 0: Not a Combination Product10/18/201810/18/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 13 PACKET
    Part 26 POUCH 2.4 mL
    Part 310 PACKET 9 g
    Part 410 PACKET 9 g
    Part 510 PACKET 14 mL
    Part 1 of 5
    AYPANAL NON-ASPIRIN 
    acetaminophen tablet
    Product Information
    Item Code (Source)NDC:0498-2001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize10mm
    FlavorImprint Code circle;U
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-2001-012 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/10/2012
    Part 2 of 5
    STING RELIEF PAD 
    ethyl alcohol, lidocaine swab
    Product Information
    Item Code (Source)NDC:0498-0733
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.5 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    10.4 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/23/2017
    Part 3 of 5
    FIRST AID BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Item Code (Source)NDC:0498-0903
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/20/2017
    Part 4 of 5
    NEOMYCIN 
    antibiotic ointment
    Product Information
    Item Code (Source)NDC:0498-0730
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0730-010.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B03/31/2010
    Part 5 of 5
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Item Code (Source)NDC:0498-0501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11.4 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/21/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/18/201810/18/2019
    4111 FIRST AID KIT 
    4111 first aid kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4111
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4111-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 13 PACKET
    Part 26 POUCH 2.4 mL
    Part 310 PACKET 9 g
    Part 410 PACKET 9 g
    Part 510 PACKET 14 mL
    Part 1 of 5
    AYPANAL NON-ASPIRIN 
    acetaminophen tablet
    Product Information
    Item Code (Source)NDC:0498-2001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize10mm
    FlavorImprint Code circle;U
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-2001-012 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/10/2012
    Part 2 of 5
    STING RELIEF PAD 
    ethyl alcohol, lidocaine swab
    Product Information
    Item Code (Source)NDC:0498-0733
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.5 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    10.4 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/23/2017
    Part 3 of 5
    FIRST AID BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Item Code (Source)NDC:0498-0903
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/20/2017
    Part 4 of 5
    NEOMYCIN 
    antibiotic ointment
    Product Information
    Item Code (Source)NDC:0498-0730
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0730-010.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B03/31/2010
    Part 5 of 5
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Item Code (Source)NDC:0498-0501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11.4 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/21/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/18/2018
    4119 FIRST AID KIT 
    4119 first aid kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4119
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4119-011 in 1 KIT; Type 0: Not a Combination Product10/18/201810/18/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 13 PACKET
    Part 26 POUCH 2.4 mL
    Part 310 PACKET 9 g
    Part 410 PACKET 9 g
    Part 510 PACKET 14 mL
    Part 1 of 5
    AYPANAL NON-ASPIRIN 
    acetaminophen tablet
    Product Information
    Item Code (Source)NDC:0498-2001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize10mm
    FlavorImprint Code circle;U
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-2001-012 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/10/2012
    Part 2 of 5
    STING RELIEF PAD 
    ethyl alcohol, lidocaine swab
    Product Information
    Item Code (Source)NDC:0498-0733
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.5 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    10.4 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/23/2017
    Part 3 of 5
    FIRST AID BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Item Code (Source)NDC:0498-0903
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/20/2017
    Part 4 of 5
    NEOMYCIN 
    antibiotic ointment
    Product Information
    Item Code (Source)NDC:0498-0730
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0730-010.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B03/31/2010
    Part 5 of 5
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Item Code (Source)NDC:0498-0501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11.4 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/21/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/18/201810/18/2019
    4120 FIRST AID KIT 
    4120 first aid kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4120
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4120-011 in 1 KIT; Type 0: Not a Combination Product10/18/201810/18/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 13 PACKET
    Part 26 POUCH 2.4 mL
    Part 310 PACKET 9 g
    Part 410 PACKET 9 g
    Part 510 PACKET 14 mL
    Part 1 of 5
    AYPANAL NON-ASPIRIN 
    acetaminophen tablet
    Product Information
    Item Code (Source)NDC:0498-2001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize10mm
    FlavorImprint Code circle;U
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-2001-012 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/10/2012
    Part 2 of 5
    STING RELIEF PAD 
    ethyl alcohol, lidocaine swab
    Product Information
    Item Code (Source)NDC:0498-0733
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.5 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    10.4 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/23/2017
    Part 3 of 5
    FIRST AID BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Item Code (Source)NDC:0498-0903
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/20/2017
    Part 4 of 5
    NEOMYCIN 
    antibiotic ointment
    Product Information
    Item Code (Source)NDC:0498-0730
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0730-010.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B03/31/2010
    Part 5 of 5
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Item Code (Source)NDC:0498-0501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11.4 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/21/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/18/201810/18/2019
    Labeler - Honeywell Safety Products USA, INC (079287321)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, INC079287321pack(0498-4107, 0498-4108, 0498-4109, 0498-4110, 0498-4111, 0498-4119, 0498-4120)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004manufacture(0498-2001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies155522589manufacture(0498-0903, 0498-0730)
    Establishment
    NameAddressID/FEIBusiness Operations
    Changzhou Maokang Medical421317073manufacture(0498-0501)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America Inc874965262manufacture(0498-0733)