Label: FIRST AID BURN CREAM cream

  • NDC Code(s): 58228-2044-1, 58228-2044-2
  • Packager: ProStat First Aid LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 16, 2023

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Active Ingredient

    Lidocaine Hydrochloride 0.5%

  • Purpose

    Benzalkonium Chloride Topical Antiseptic

    Lidocaine Hydrochloride Topical Analgesic

  • Use(s)

    • For the temporary relief of pain and itching associated with:

    • Sunburn • Minor burns • Insect bites • Minor skin irritation • Cuts • Scrapes

  • Warnings

    For External Use Only

    Do not use

    • In the eyes

    • Over large areas of the body or on deep puncture wounds, animal bites, or serious burns

    • In large quantities, particularly over raw surfaces or blistered areas

    Stop use and ask a dioctor if

    • The condition gets worse

    • Condition clears up and recurs within a few days

    • Condition persists for more than 7 days

    If pregnant or breast feeding

    ask a health care professional before use.

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    Adults and children 2 years and over:

    • Clean the affected area

    • Apply a small amount of this product on the area 3 to 4 times daily

    • May be covered with a sterile bandage

    Children under 2 years:

    • Consult a doctor

  • Other Information

    • Store in a cool, dry area 15º-25ºC (59º-77ºF)

    • Tamper evident sealed packets

    • Do not use any opened or torn packets

  • Inactive Ingredients

    Butylated Hydroxytoluene, Cetomacrogol 1000, Cetostearyl Alcohol, Dimethicone, Glycerine, Glyceryl Monostearate, Isopropyl Myristate, Methylcellulose, Purified Water, Sodium EDTA, Sodium Methylparaben, Sodium Propylparaben

  • Questions?

    1-888-900-2920 Monday - Friday 8AM - 4PM PST.

  • Label

    PS-2044-BX-MASTERFirst Aid Burn Cream

  • INGREDIENTS AND APPEARANCE
    FIRST AID BURN CREAM 
    first aid burn cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58228-2044
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C16) (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C16)0.13 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    METHYLCELLULOSE (4000 CPS) (UNII: MRJ667KA5E)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CETETH-20 (UNII: I835H2IHHX)  
    DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
    Product Characteristics
    Color    Score    
    ShapeFREEFORMSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58228-2044-21800 in 1 CASE04/10/2023
    1NDC:58228-2044-125 in 1 BOX
    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 finalpart34804/10/2023
    Labeler - ProStat First Aid LLC (061263699)
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