Label: 4191 FIRST AID KIT- 4191 first aid kit

  • NDC Code(s): 0498-0100-01, 0498-0121-00, 0498-0203-00, 0498-0733-00, view more
    0498-3334-00, 0498-4191-01
  • 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 March 9, 2019

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

  • Active ingredient

    Ammonia 15%

  • Purpose

    Respiratory stimulant

  • Uses

    to prevent or treat fainting

  • Warnings

    For external use only

    Do not use

    • if you have 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.

  • 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
  • Other information

    store at room temperature away from light

  • Inactive ingredients

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

  • 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

  • Sting Relief Active ingredient (in each wipe)

    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 ingredient

    benzalkonium chloride, menthol, and purified water

  • Sting Relief Questions or Comments?

    1-800-430-5490

  • PVP Active ingredient

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

  • PVP Purpose

    First aid antisepti

  • PVP Uses

    • first aid to help prevent the risk of infection in minor cuts, scrapes, and burn
  • PVP Warnings

    For external use only

    Do not use

    • in the eyes
    • 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
  • PVP Directioons

    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
  • PVP Other information

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

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

  • PVP Questions and Comments?

    1-800-430-5490

  • 4191 010875-0349 Kit Contents

    1 KNUCKLE BAND 8 PER

    1 AMMONIA INHALANTS 10 PER

    1 GAUZE BANDAGE, 4" X 6 YD

    1 TOURNIQUET, 1 PER

    1 TRIANGULAR BDG, NON-STERILE

    1 WIRE SPLINT 1 PER

    1 GAUZE COMP, 1 SQ YARD, 1 PER

    1 BANDAGE COMP, 2" OFFSET, 4 PER

    1 BANDAGE COMP, 4" OFFSET, 1 PER

    1 ADHESIVE BDG,PLSTIC,1"X3"16PER

    1 FINGERTIP BANDAGE, 10 PER

    1 1 OZ EYE WASH W/PADS & STRIPS

    1 BURN JEL 1/8 OZ, 6 PER

    2 PVP IODINE WIPES 10 PER

    LBL STOCK 6-3/8"X4"

    1 LBL STOCK 3"x1-7/8"

    1 LBL CONTS 6 3/4"X3 1/2" ID B

    1 KIT STL 16 UN (VERTICAL)

    1 INSERT FA INSTR 16UN PHIL ELEC

    1 58 LBL REFILL 010875-0349

    1 NOX A STING WIPES 10

  • Principal Display Panel

    Inhalant

  • Burn Jel Principal Display Panel

    Burn Jel

  • Sting Relief Principal Display Panel

    Sting Relief

  • PVP Principal Display Panel

    PVP Swab

  • 4191 Kit Label 010875-0349

    4191 label

  • INGREDIENTS AND APPEARANCE
    4191 FIRST AID KIT 
    4191 first aid kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4191
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4191-011 in 1 KIT09/13/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 110 AMPULE 3 mL
    Part 26 PACKET 21 g
    Part 310 POUCH 4 mL
    Part 420 POUCH 6 mL
    Part 51 BOTTLE 30 mL
    Part 1 of 5
    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 2 of 5
    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
    TEA TREE OIL (UNII: VIF565UC2G)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    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 3 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
    1NDC:0498-0733-000.4 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 4 of 5
    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 5
    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 PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/13/2018
    Labeler - Honeywell Safety Products USA, Inc. (079287321)
    Registrant - Honeywell Safety Products USA, Inc. (079287321)
    Establishment
    NameAddressID/FEIBusiness Operations
    James Alexander040756421manufacture(0498-3334)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, Inc079287321pack(0498-4191)
    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, Inc.874965262manufacture(0498-0733)