Label: 4311 FIRST AID KIT- 4311 first aid kit

  • NDC Code(s): 0498-0100-01, 0498-0121-00, 0498-0143-04, 0498-0203-00, view more
    0498-0733-00, 0498-4311-01
  • 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.

  • 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 Purposse

    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

  • Eyewash Active ingredient

    Sterile Water 99%

  • Eyewassh Purpose

    Eyewash

  • Eyewash Uses

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

  • Eyeash 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
  • Eyewash Inactive ingredients

    sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

  • Eyeash Questions

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

  • Alcohol Active ingredient

    Isopropyl alcohol 70%

  • Alcohol Purpose

    First aid antiseptic

  • Alcohol Uses

    first aid to help prevent infection in

    • minor cuts
    • scrapes
    • burns
  • Alcohol Warnings

    For external use only

    Flammable, keep away from fire and flame

    Do not use

    • in or near 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 1 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 Directions

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

    • store at room temperature 15 0 to 25 0 C (59 0 to 77 0 F)
    • do not use if packet is torn or opened
  • Alcohol Inactive ingredient

    water

  • Alcohol Questions

    1-800-430-5490

  • PVP Active ingredient

    Povidone-iodine 10% (equivalent to 1% titratable iodine)

  • PVP Purpose

    First aid antiseptic

  • PVP Uses

    • first aid antiseptic to help prevent infection in minor cuts, scrapes and burns
  • PVP Warnings


    For external use only.

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

    Keep out of reach of children.

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

  • PVP Directions

    • clean the affected area
    • apply1 to 3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first
    • discard wipe after single use
  • PVP Other information

    • do not use on individuals who are allergic or sensitive to iodine
    • store at controlled temperature 59-86ºF (15-30ºC)
    • do not use if pouch is open or torn

  • PVP Inactive ingredients

    nonoxynol 9, water

  • 4311 SF00004446 Kit Contents

    1 KNUCKLE BAND 8 PER

    2 INSTANT COLD PACK 4" X 6"

    1 BUFFERED EYE WASH 1 OZ BTL

    1 BANDAGE COMP, 4" OFFSET, 1 PER

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

    1 BURN JEL 1/8 OZ, 6 PER

    1 ALCOHOL PREP PADS 10P

    1 PVP IODINE WIPES 10 PER

    1 STING RELIEF WIPES 10 PER BOX

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

    1 POISON OAK/IVY CLEANSER 4 OZ

    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 16 UN (HORIZONTAL)

  • Burn Jel Principal Display Panel

    Burn Jel

  • Sting Relief Principal Display Panel

    Sting Relief

  • Eyewash Principal Display Panel

    Eyesaline

  • Alcohol Principal Display Panel

    Alcohol Preps

  • PVP Principal Display Panel

    PVP Wipe

  • 4311 Kit Label SF00004446

    4311 label

  • INGREDIENTS AND APPEARANCE
    4311 FIRST AID KIT 
    4311 first aid kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4311
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4311-011 in 1 KIT09/13/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 16 PACKET 21 g
    Part 21 BOTTLE 30 mL
    Part 310 POUCH 4 mL
    Part 410 POUCH 4 mL
    Part 510 POUCH 3 mL
    Part 1 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 2 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
    Part 3 of 5
    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 4 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 5 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
    WATER (UNII: 059QF0KO0R)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    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
    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
    Honeywell Safety Products USA, Inc079287321pack(0498-4311)
    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
    Changzhou Maokang Medical421317073manufacture(0498-0143)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sion Medical Biotext532775194manufacture(0498-0121)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America Inc874965262manufacture(0498-0733)