Label: EASY CARE FIRST AID AFTERBURN- benzalkonium chloride, lidocaine cream

  • 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 September 30, 2019

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  • Active Ingredients

    Benzalkonium Chloride 0.13%
    Lidocaine HCL 0.5%

  • Purpose

    First Aid Antiseptic

    Topical Analgesic

  • Uses

    • temporary relief of pain associated with minor burns
    • helps protect against harmful bacteria
  • Warnings

    For external use only.


  • Do not use

    • in the eyes
    • in large quantities
    • on animal bites, serious burns, deep puncture wounds, raw surfaces, or blistered areas
    • for more than one week unless directed to do so by a doctor
  • Stop use and ask a doctor if

    • condition worsens
    • if symptoms persist for more than 7 days or clears up and occurs again within a few days

  • Keep out of Reach of Children

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

  • Directions

    • adults and children 2 years of age and older: clean the affected area; apply a small amount to the area 1-3 times daily; may be covered with a sterile bandage (let dry first).
    • children under 2 years of age: consult a doctor

  • Inactive Ingredients

    glycerin monostearate, glycerol, purified water, sodium dodecyl sulfate

  • PRINCIPAL DISPLAY PANEL

    Easy Care First Aid
    AfterBurn Cream

    Serious Treatment for Burns

    Responsibly Made in China for
    Tender Corporation
    Littleton, NH 03561
    afterburnrelief.com

    AfterBurn Burn Cream

  • INGREDIENTS AND APPEARANCE
    EASY CARE FIRST AID AFTERBURN 
    benzalkonium chloride, lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44224-0012
    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 HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44224-0012-10.9 g in 1 PACKET; Type 0: Not a Combination Product09/01/2019
    2NDC:44224-0012-26 in 1 BOX09/01/2019
    20.9 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:44224-0012-3100 in 1 CARTON09/01/2019
    30.9 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 finalpart333A09/01/2019
    Labeler - Tender Corporation (064437304)
    Establishment
    NameAddressID/FEIBusiness Operations
    GFA Production (Xiamen) Co., Ltd. 421256261manufacture(44224-0012)
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