Label: 4128 FIRST AID KIT kit

  • NDC Code(s): 0498-0501-00, 0498-4128-01
  • 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 7, 2019

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

  • First Aid Burn Cream Active ingredient

    Benzalkonium chloride 0.13%

    Lidocaine HCl 0.5%

  • First Aid Burn Cream Purpose

    First Aid antiseptic

    External analgesic

  • First Aid Burn Cream Uses

    • prevent skin infection
    • for temporary relief of pain associated with minor burns
  • First Aid Burn Cream Warnings

    For external use only

    Do not use

    • in or near the eyes
    • if you are allergic to any of the ingredients
    • in large areas of the body, particularly over raw surfaces or blistered areas
    • for more than 10 days


    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
    • symptoms persist for more than 7 days or clear up and occurs again within a few days
  • First Aid Burn Cream Directions

    • adults and children 2 years of age and older:
    • clean the affected area
    • apply a small amount of this product (equal to the surface area of the tip of a finger) onto affected area 1 to 3 times daily
    • may be covered with a sterile bandage
    • children under 2 years of age: consult a doctor
  • First Aid Burn Cream Other information

    • tamper evident sealed packets
    • do not use if packet is opened or torn
  • First Aid Burn Cream Inactive ingredients

    aloe barbadensis juice, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl stearate SE, methylparaben, mineral oil, PEG-100, propylene glycol, propylparaben, stearic acid, trolamine, water

  • First Aid Burn Cream Questions

    1-800-430-5490

  • BZK Active ingredient

    Benzalkonium chloride 0.13% w/v

  • BZK Purpose

    First aid antiseptic

  • BZK Uses

    Antiseptic cleansing of face, hands, and body without soap and water

  • BZK Warnings


    For external use only

    Do not use

    • in the eyes or over large areas of the body
    • on mucous membranes
    • on irritated skin
    • in case of deep puncture wounds, animal bites or serious burns, consult a doctor
    • longer than 1 week unless directed by a doctor

    Keep out of reach of children

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

    Stop use and ask a doctor if

    • irritation, redness or other symptoms develop
    • the condition persists or gets worse
  • BZK Directions

    • tear open packet and use as a washcloth
  • BZK Other information

    • store at room temperature 15 0 to 30 0 C (59 0 - 86 0 F)
    • do not reuse towelette
  • BZK Inactive ingredients

    water

  • BZK Questions

    1-800-430-5490

  • 4128 SF00004238 Kit Contents

    LBL STOCK 6-3/8"X4"

    1 LBL STOCK 3"x1-7/8"

    4 BZK ANTISEPTIC WIPE, BULK

    4 FIRST AID CREAM 1.0GR PKT EACH

    1 KIT PP PROMOTIONAL FA KIT

    10 ADH BANDAGE 3/8" X 1 1/2" DNX

    8 PLASTIC BANDAGE 3/4" X 3"

    2 WOVEN KNUCKLE BANDAGE

    2 HEAVY FLEX LARGE PATCH 2" X 3"

  • First Aid Burn Cream Principal Display Panel

    FABC label

  • BZK Principal Display Panel

    Antiseptic Wipe

  • 4128 Kit Label SF00004238

    4128 Label

  • INGREDIENTS AND APPEARANCE
    4128 FIRST AID KIT 
    4128 first aid kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4128
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4128-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 14 PACKET 3.6 g
    Part 24 PACKET 5.4 mL
    Part 1 of 2
    FIRST AID BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Item Code (Source)NDC:0498-0903
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/20/2017
    Part 2 of 2
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Item Code (Source)NDC:0498-0501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0501-001.4 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 finalpart333E09/18/2018
    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(0498-4128)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies155522589manufacture(0498-0903)
    Establishment
    NameAddressID/FEIBusiness Operations
    Changzhou Maokang Medical421317073manufacture(0498-0501)