4236 FIRST AID KIT KIT [HONEYWELL SAFETY PRODUCTS USA, INC.]

4236 FIRST AID KIT KIT [HONEYWELL SAFETY PRODUCTS USA, INC.]
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NDC 0498-0121-00, 0498-0202-00, 0498-4236-01
Set ID 8531b218-5872-536d-e053-2a91aa0a8b26
Category HUMAN OTC DRUG LABEL
Packager Honeywell Safety Products USA, Inc.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number
  • 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
  • Burn Jel 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

  • PVP Wipe Active ingredient

    Povidone-iodine 10%

    (equivalent to 1% titratable iodine)

  • PVP Wipe Purpose

    First aid antiseptic

  • PVP Wipe Uses

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

  • PVP Wipe 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

  • PVP Wipe Keep out of reach of children

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

  • PVP Wipe 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 Wipe 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 Wipe Inactive ingredients

    nonoxynol 9, water

  • PVP Wipe Questions

    800-430-5490

  • 4236 6824COS Kit Contents

    1 EYE DRESS PKT W/4 ADH STRIPS

    6 TRIANGULAR BDG, NON-STERILE

    2 GAUZE COMPRESS, 1728 SQ IN 1

    1 INSTANT COLD PACK 4" X 6"

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

    1 BURN JEL 1/8 OZ, 6 PER

    2 PVP IODINE WIPES 10 PER

    1 NITRILE GLOVES 2PR BBP

    1 FIRST AID GUIDE ASHI

    2 BANDAGE COMP 4" W/TELFA PAD 1

    LBL STOCK 6-3/8"X4"

    LBL STOCK 4"X2-7/8"

    1 LBL STOCK 3"x1-7/8"

    1 KIT STL 24 UN WHITE 01

    1 WOVEN KNUCKLE 8'S

    1 FINGERTIP "T" 8/BX

    1 GAUZE PADS 3"X3" 4/BX

    1 SCISSOR & FORCEP 1 EA

  • Burn Jel Principal Display Panel

    Burn Jel

  • PVP Wipe Principal Display Panel

    PVP wipes

  • 4236 Kit Label 6824COS

    4236 label

  • INGREDIENTS AND APPEARANCE
    4236 FIRST AID KIT 
    4236 first aid kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4236
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4236-011 in 1 KIT09/12/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 16 PACKET 21 mL
    Part 220 POUCH 6 mL
    Part 1 of 2
    BURN JEL 
    gel for burns gel
    Product Information
    Item Code (Source)NDC:0498-0202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    OCTOXYNOL 9 (UNII: 7JPC6Y25QS)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0202-003.5 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 finalpart34812/08/2017
    Part 2 of 2
    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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/12/2018
    Labeler - Honeywell Safety Products USA, Inc. (079287321)
    Registrant - Honeywell Safety Products US, Inc. (079287321)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, Inc079287321pack(0498-4236)

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