Label: 4203 FIRST AID KIT kit
4256 FIRST AID KIT kit

  • NDC Code(s): 0498-0100-02, 0498-0121-00, 0498-0143-04, 0498-0221-59, view more
    0498-0402-59, 0498-0730-01, 0498-4203-01, 0498-4256-01
  • 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 April 8, 2019

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

  • Eyesaline Active ingredient

    Sterile Water 99%

  • Eyesaline Purpose

    Eyewash

  • Eyesaline Uses

    • for flushing the eye to remove loose foreign material, air pollutants or chlorinated water
  • Eyesaline Warnings

    For external use only-

    Obtain immediate medical treatment for all open wounds in or near eyes.

    To avoid contamination, do not touch tip of container to any surface.

    Do not reuse. Once opened, discard.

    Do not use

    • if solution changes color or becomes cloudy
    • if you have open wounds in or near the eyes, get medical help right away.

    Stop use and ask a doctor if

    • you experience eye pain
    • changes in vision
    • continued redness or irritation of the eye
    • condition worsens or persists


    Keep out of reach of children


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

  • Eyesaline Directions

    • remove contacts before using
    • twist top to remove
    • flush the affected area as needed
    • control rate of flow by pressure on the bottle
    • if necessary, continue flushing with emergency eyewash or shower
  • Eyesaline Inactive ingredients

    sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

  • Eyesaline Questions

    1-800-430-5490 Honeywell Sadety Products USA, Inc. Smithfield, RI 02917

  • Povidone Iodine Swab Active ingredient

    Povidone-iodine solution USP, 10% (equivalent to 1% titratable iodine)

  • Povidone Iodine Swab Purpose

    First aid antiseptic

  • Povidone Iodine Swab Uses

    • first aid to help prevent the risk of infection in minor cuts, scrapes, and burns
  • Povidone Iodine Swab Warnings


    For external use only

    Do not use

    • over large areas of the body
    • on individuals who are allergic or sensitive to iodine

    Ask a doctor before use if you have

    • deep or puncture wounds,
    • animal bites
    • serious burns

    When using this product

    • do not use longer than one wek unless directed by a doctor

    Stop use and ask a doctor if

    • conditions persists or gets worse
    • irritation and redness develops

    Keep out of reach of children

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

  • Povidone Iodine Swab Directions

    Reverse cardboard sleeve, then crush at dot between thumb and forefinger. Allow solution to saturate tip and apply solution to injury.

    • clean affected area
    • apply to affected area 1 to 3 times daily
    • may be covered with a sterile bandage
    • discard swab after single use
  • Povidone Iodine Swab Other information

    • store at room temperature away from light
    • keep from freezing or excessive heat
    • do not use if package is torn or open
  • Povidone Iodine Swab Inactive ingredients


    citric acid, disodium phosphate,nonoxynol-9, sodium hydroxide, water

  • Povidone Iodine Swab Questions and comments

    1-800-430-5490

  • Alcohol Wipe Active ingredient

    Isopropyl alcohol 70%

  • Alcohol Wipe Purpose

    First aid antiseptic

  • Alcohol Wipe Uses

    • first aid to help prevent infection in minor cuts, scrapes, and burns
  • Alcohol Wipe 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 burn


    When using this product

    • do not use longer than one week unless directed by a doctor


    Stop use and consult a doctor

    • if condition persists or gets worse

    Keep out of reach of children

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Alcohol Wipe Directions

    • clean the affected area
    • apply wipe to affected area 1 to 3 times daily
    • may be covered with a sterile bandage
    • discard wipe after single use
  • Alcohol Wipe Other information

    store at room temperature 15 0 to 25 0 C (59 0 to 77 0F)

  • Alcohol Wipe Inactive ingredient

    water

  • Alcohol Wipe Questions

    1-800-430-5490

  • Aypanal Active ingredient

    Acetaminophen 325 mg

  • Aypanal Purpose

    Pain reliever/ fever reducer

  • Aypanaly Uses

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

    Keep out of reach of children.

    Keep out of reach of children.

  • 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 more than 5 doses in 24 hours, which is the maximum daily amount
    • taken with other drugs containing acetaminophen
    • adult has 3 or more alcoholic drinks every day while using this product:

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

    • skin reddening
    • blisters
    • rash
    • If a skin rash occurs, stop use and seek medical help right away.

    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


    Stop using and ask a doctor if

    • pain gets worse or lasts more than 10 days in adults
    • pain gets worse or lasts more than 5 days in children under 12 years
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur

    If pregnant or breast-feeding

    If pregnant or breast-feeding, ask a health professional before use.


    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 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 0 to 30 0 C (59 0 - 86 0 F)
    • 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

    1-800-430-5490

  • Neomycin Active ingredient

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

  • Neomycin Purpose

    First aid antibiotic

  • Neomycin Uses

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

    Do not use

    • in the eyes
    • over large areas of the body
  • Neomycin 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

    • a rash or other allergic reaction develops
    • you need to use longer than 1 week

    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 Direction

    • 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 Other information


    store at 15 0 to 25 0 C (59 0 to 77 0 F)

  • Neomycin Inactive ingredient

    petrolatum

  • Neomycin Questions?

    1-800-430-5490

  • Antiseptic Spray Active ingredient

    Benzalkonium chloride 0.13%

  • Antiseptic Spray Purpose

    First aid antiseptic

  • Antiseptic Spray Uses

    • first aid to help prevent infection in minor cuts, scrapes and burns
  • Antiseptic Spray Warnings

    For external use only

    Do not use

    • in or near the eyes
    • over large areas of the body

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product

    • do not use longer than one week unless directed by a doctor

    Stop use and ask a doctor if

    • 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
  • Antiseptic Spray Directions

    • clean the affected area
    • spray a small amount of this product on the area 1 to 3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first
  • Antiseptic Spray Other information

    • shake well
    • store at room temperature 15 0-30 0 C (59 0 -86 0 F)
  • Antiseptic Spray Inactive ingredients

    diazolidinyl urea, edetate disodium, glycerin, hypromellose, methylparaben, octoxynol 9, propylene glycol, propylparaben, trolamine, water

  • Antiseptic Spray Questions

    1-800-430-5490

  • Burn Spray Active ingredient

    Benzethonium chloride 0.2% w/w

    Benzocaine 10% w/w

    Menthol 0.33% w/w

  • Burn Spray Purpose

    Benzethonium chloride 0.2% w/w

    Benzocaine 10% w/w

    Menthol 0.33% w/w

  • Burn Spray Uses

    for the temporary relief of pain and itching and helps protect against infection in:

    • minor cuts and scrapes
    • burns
    • sunburn
    • insect bites
    • minor skin irritations
  • Burn Spray Warnings

    For external use only

    Flammable

    • keep away from fire or flame
    • contents under pressure
    • do not puncture or incinerate container
    • do not expose to temperatures above 120 0 F

    Do not use

    • in or near the eyes or other mucous membranes
    • in case of serious burns
    • in case of deep or puncture wounds
    • for prolonged period of time
    • on large portion of the body

    Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days
    • condition clears up and recurs within a few days
    • redness, swelling, or irritation occurs

    Keep out of the reach of children

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Burn Spray Directions

    • clean the affected area
    • shake can well before using
    • hold 4 - 6 inches from surface and spray area until wet
    • may be covered with a sterile bandage, if bandaged let dry first
    • for adult institutional use only
    • not intended for use on children
  • Burn Spray Other information

    • avoid inhaling
    • use only as directed
    • intentional misuse by deliberately concentrating or inhaling the contents may be harmful or fatal
  • Burn Spray Inactive ingredients

    dipropylene glycol, isobutane, n-butane, propane

  • 4256 Z019720-0009L Kit Contents

    2 1X3 PLASTIC 100/BOX

    1 FINGERTIP "T" WOVEN 40/BOX

    1 SWIFT KNUCKLE 40/BX

    1 3/4 X 3 WOVEN 100/BOX

    1 NEOMYCIN ANTIBIOTIC 10 PER

    1 EYE DRESS PKT W/4 ADH STRIPS

    2 ALCOHOL PREP PADS 10P

    4 PVP IODINE WIPES 10 PER

    1 TWEEZER PLASTICS 4"

    1 ADH BAND PLSTC EX-LG 25 PER

    1 O/H PUMP ANTISEPTIC 2 OZ ID F

    1 O/H PUMP BURN RELIEF 2 OZ ID G

    1 FIRST AID GUIDE ASHI

    1 TAPE ADHESIVE 1"X 5 YD PLSTC

    4 GAUZE CLEAN-WRAP BDGE N/S 2"

    4 GAUZE CLEAN-WRAP BDGE N/S 3"

    1 BLOODSTOPPER

    1 NON-ADHERENT PADS 2"X3" 10'S

    1 GZE PADS STERILE 2"X 2" 10'S

    1 GZE PADS STERILE 3"X 3" 25'S

    1 ELASTIC BANDAGE 3" X 4.5YD

    1 CPR FILTERSHIELD 77-100

    1 AYPANAL NON-ASP IND 2/ENV 100

    1 4OZ BFS EYEWASH TRILINGUAL BOTTLE

    1 SCISSOR BDGE 4" RED PLS HDL

    1 LBL STOCK 6-3/8"X4"

    1 LBL STOCK 4"X2-7/8"

    5 PR LRG NITRILE GLVES ZIP BAG

    1 KIT ST MED FA CABINET-SP SHELF

    1 LBL CONTENTS ANSI Z308.1-2009 REV B

    1 LBL CAB CVR FA LOGO NORTH ID B

    1 TRI BNDG NON WOVEN 40"X40"X56"

    2 COLD PACK UNIT 4"X6" BULK

  • Eyesaline Principal Display Panel

    Eyesaline

  • Povidone Iodine Swab Principal Display Panel

    PVP Swab

  • Alcohol Wipe Principal Display Panel

    OH Pak Alcohol Wipe

  • Aypanal Principal Display Panel

    Aypanal

  • Neomycin Principal Display Panel

    Neomycin

  • Antiseptic Spray Principal Display Panel

    Antiseptic Spray

  • Burn Spray Principal Display Panel

    Burn Spray

  • 4203 Kit Label 019720-0009L

    4203 Kit Label

  • 4203 Kit Contnets 019720-0009L

    1 1X3 PLASTIC 100/BOX
    1 FINGERTIP "T" WOVEN 40/BOX
    1 SWIFT KNUCKLE 40/BX
    1 3/4 X 3 WOVEN 100/BOX
    1 NEOMYCIN ANTIBIOTIC 10 PER
    1 EYE DRESS PKT W/4 ADH STRIPS
    2 ALCOHOL PREP PADS 10P
    4 PVP IODINE WIPES 10 PER
    1 TWEEZER PLASTICS 4"
    1 ADH BAND PLSTC EX-LG 25 PER
    1 O/H PUMP ANTISEPTIC 2 OZ ID F
    1 O/H PUMP BURN RELIEF 2 OZ ID G
    1 FIRST AID GUIDE ASHI
    1 TAPE ADHESIVE 1"X 5 YD PLSTC
    4 GAUZE CLEAN-WRAP BDGE N/S 2"
    4 GAUZE CLEAN-WRAP BDGE N/S 3"
    1 BLOODSTOPPER
    1 NON-ADHERENT PADS 2"X3" 10'S
    1 GZE PADS STERILE 2"X 2" 10'S
    1 GZE PADS STERILE 3"X 3" 25'S
    1 ELASTIC BANDAGE 3" X 4.5YD
    1 CPR FILTERSHIELD 77-100
    1 AYPANAL NON-ASP IND 2/ENV 100
    1 4OZ BFS EYEWASH TRILINGUAL BOTTLE
    1 SCISSOR BDGE 4" RED PLS HDL
    1 5 PR LRG NITRILE GLVES ZIP BAG
    1 KIT ST MED FA CABINET-SP SHELF
    1 LBL CONTENTS ANSI Z308.1-2009 REV B
    1 TRI BNDG NON WOVEN 40"X40"X56"
    2 COLD PACK UNIT 4"X6" BULK

  • 4256 Kit Label Z019720-0009L

    4256 label

  • INGREDIENTS AND APPEARANCE
    4203 FIRST AID KIT 
    4203 first aid kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4203
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4203-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 118 mL
    Part 220 POUCH 8 mL
    Part 340 POUCH 12 mL
    Part 450 PACKET 100 
    Part 51 BOTTLE, SPRAY 59 mL
    Part 61 BOTTLE, SPRAY 59 mL
    Part 710 PACKET 9 g
    Part 1 of 7
    EYESALINE EMERGENCY EYEWASH 
    purified water liquid
    Product Information
    Item Code (Source)NDC:0498-0100
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.6 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0100-02118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34912/18/2018
    Part 2 of 7
    ALCOHOL WIPE 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC:0498-0143
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0143-040.4 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 finalpart333A09/18/2018
    Part 3 of 7
    PVP IODINE WIPE 
    povidone-iodine 10% swab
    Product Information
    Item Code (Source)NDC:0498-0121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0121-000.3 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/18/2018
    Part 4 of 7
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize10mm
    FlavorImprint Code circle;U
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12 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 5 of 7
    BURN RELIEF 
    lidocaine hydrochloride spray
    Product Information
    Item Code (Source)NDC:0498-0221
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS24.64 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0221-5959 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/18/2018
    Part 6 of 7
    ANTISEPTIC 
    benzalkonium chloride spray
    Product Information
    Item Code (Source)NDC:0498-0402
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    OCTOXYNOL 9 (UNII: 7JPC6Y25QS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0402-5959 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/18/2018
    Part 7 of 7
    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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/18/2018
    4256 FIRST AID KIT 
    4256 first aid kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4256
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4256-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 118 mL
    Part 220 POUCH 8 mL
    Part 340 POUCH 12 mL
    Part 450 PACKET 100 
    Part 51 BOTTLE, SPRAY 59 mL
    Part 61 BOTTLE, SPRAY 59 mL
    Part 710 PACKET 9 g
    Part 1 of 7
    EYESALINE EMERGENCY EYEWASH 
    purified water liquid
    Product Information
    Item Code (Source)NDC:0498-0100
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.6 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0100-02118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34912/18/2018
    Part 2 of 7
    ALCOHOL WIPE 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC:0498-0143
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0143-040.4 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 finalpart333A09/18/2018
    Part 3 of 7
    PVP IODINE WIPE 
    povidone-iodine 10% swab
    Product Information
    Item Code (Source)NDC:0498-0121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0121-000.3 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/18/2018
    Part 4 of 7
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize10mm
    FlavorImprint Code circle;U
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12 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 5 of 7
    BURN RELIEF 
    lidocaine hydrochloride spray
    Product Information
    Item Code (Source)NDC:0498-0221
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS24.64 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0221-5959 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/18/2018
    Part 6 of 7
    ANTISEPTIC 
    benzalkonium chloride spray
    Product Information
    Item Code (Source)NDC:0498-0402
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    OCTOXYNOL 9 (UNII: 7JPC6Y25QS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0402-5959 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/18/2018
    Part 7 of 7
    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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/18/2018
    Labeler - Honeywell Safety Products USA, INC (079287321)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, INC079287321pack(0498-4203, 0498-4256)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004manufacture(0498-2001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies155522589manufacture(0498-0730, 0498-0402, 0498-0221)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, Inc.167518617manufacture(0498-0100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Changzhou Maokang Medical421317073manufacture(0498-0143)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sion Biotext Medical532775194manufacture(0498-0121)