Label: 4308 FIRST AID KIT kit

  • NDC Code(s): 0498-0100-01, 0498-0121-00, 0498-0203-00, 0498-3334-00, view more
    0498-4308-01
  • 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 May 10, 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

  • Ammonia Inhalent Active ingredient

    Ammonia 15%

  • Ammonia Inhalent Purpose

    Respiratory stimulant

  • Ammonia Inhalent Uses

    • to prevent or tret fainting
  • Ammonia Inhalent Warnings

    For external use only

    Do not use

    • if you have breathing problems such as asthma or emphysema

    Stop use and ask a doctor if

    • condition persists

    Keep out of reach of children

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

  • Ammonia Inhalent Directions

    • hold inhalant away from face and crush ampoule between thumb and forefinger at position indicated on sleeve.
    • hold near nostrils for inhalation of volatile vapor
  • Ammonia Inhalent Other information

    • store at room temperature away from light
  • Ammonia Inhalent Other information

    • store at room temperature away from light
  • Ammonia Inhalent Inactive ingredients

    alcohol USP, FD&C red #40, lavender oil, lemon oil fcc, nutmeg oil, purified water

  • Ammonia Inhalent Questions or Comments

    1-800-430-5490

  • Burn Jel Active ingredient

    Lidocaine HCl 2.0%

  • Burn Jel Purpose

    External analgesic

  • Burn Jel Uses

    • temporarily relieves pain due to minor burns
  • Burn Jel Warnings

    For external use only

    Do not use

    • on large areas of the body, particularly over raw surfaces or blistered areas

    When using this product

    • avoid contact with eyes

    Stop use and ask a doctor if

    • the condition gets worse
    • symptoms persist for more than 7 days
    • condition clears up and recurs within a few days

    Keep out of reach of children

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

    • adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: ask a doctor
    • you may report a serious reaction to this product to 800-430-5490
  • Burn Jel Other information

    • store at room temperature
    • do not use if opened or torn
  • Burn Jel Inactive ingredients

    carbopol 940, carbopol 1342, diazolidinyl urea, glycerin, melaleuca alternifolia (tea tree) leaf oil, methylparaben, octoxynol-9, propylene glycol, propylparaben, trolamine, water ...

  • Burn Jel Questions

    1-800-430-5490

  • 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

  • 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

  • PAWS Active ingredient

    Ethyl alcohol 66.5%

  • PAWS Purpose

    Antiseptic

  • PAWS USes

    • for handwashing to decrease bacteria on skin whenever soap and water is not readily available

  • PAWS Warnings

    For external use only

    Flammable: keep away from fire or flame

    Do not use in the eyes.

    If this happens, rinse thoroughly with water.

    Stop use and ask a doctor if

    • irritation or redness develop and persists for more than 72 hours

    Keep out of reach of children

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

  • PAWS Directions

    • wet hands and wrists thoroughly for 15 seconds and allow to air dry
    • always reseal after use
    • children under 6 years of age should be supervised when using this product

  • PAWS Inactive ingredients


    aloe vera, fragrance, purified water, triethanolamine

  • PAWS Questions

    1-800-430-5490

  • 4308 SF00004419 Kit Contents

    1 3/4 X 3 PLAS 100/BOX

    1 GAUZE BANDAGE, 4" X 6 YD

    2 INSTANT COLD PACK 4" X 6"

    1 BURN JEL 1/8 OZ, 6 PER

    1 ADHESIVE TAPE W/P 1/2"X 5 YD

    1 FIRST AID GUIDE ASHI

    0.2 CARTON DISP COOL JEL 1/8 OZ

    1 GZE PADS STERILE 3"X 3" 10'S

    5 CO-FLEX BAND 1"X5YD TAN 2/PACK

    6 PVP PREP PADS MEDIUM

    6 PAWS PERS ANTIMICRO WIPE

    1 OZ, BUFF EYEWASH

    1 SCISSOR BDGE 4" RED PLS HDL

    1 KIT TWEEZER 3 1/2" SLANTED

    LBL STOCK 6-3/8"X4"

    LBL STOCK 4"X2-7/8"

    1 LBL STOCK 3"x1-7/8"

    2 PR LRG NITRILE GLVES ZIP BAG

    1 KIT STL BULK MEDIUM

    1 TRI BNDG NON WOVEN 40"X40"X56"

    4 EYE PADS STD OVAL STERILE

    1 WOVEN KNUCKLE 8'S

    2 AYPANAL NON-ASP 25/2

    5 AMMONIA INHALANT, BULK

  • Eyesaline Principal Display Panel

    Eyesaline

  • Ammonia inhalent Principal Display Panel

    Ammonia Inhalant

  • Burn Jel Principal Display Panel

    Burn Jel

  • Povidone Iodine Swab Principal Display Panel

    PVP Swab

  • Aypanal Principal Display Panel

    Aypanal

  • PAWS Principal Display Panel

    PAWS

  • 4308 Kit Label SF00004419

    4308 label

  • INGREDIENTS AND APPEARANCE
    4308 FIRST AID KIT 
    4308 first aid kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4308
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4308-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 30 mL
    Part 25 AMPULE 1.5 mL
    Part 36 PACKET 0.0114 L
    Part 46 POUCH 1.8 mL
    Part 56 PACKET 21 g
    Part 650 PACKET 100 
    Part 1 of 6
    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:0498-0100-0130 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 6
    AMMONIA INHALENT 
    ammonia inhalent inhalant
    Product Information
    Item Code (Source)NDC:0498-3334
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA0.045 g  in 0.3 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-3334-000.3 mL in 1 AMPULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/18/2018
    Part 3 of 6
    PAWS 
    ethyl alcohol liquid
    Product Information
    Item Code (Source)NDC:0498-3111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL665 mL  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    10.0019 L 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
    Part 4 of 6
    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 5 of 6
    BURN JEL 
    gel for burns gel
    Product Information
    Item Code (Source)NDC:0498-0203
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0203-003.5 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 finalpart34809/19/2018
    Part 6 of 6
    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
    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
    James Alexander040756421manufacture(0498-3334)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, INC079287321pack(0498-4308)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004manufacture(0498-2001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies155522589manufacture(0498-0203)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, Inc.167518617manufacture(0498-0100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sion Biotext Medical532775194manufacture(0498-0121)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America Inc874965262manufacture(0498-3111)