Label: GENUINE FIRST AID ALCOHOL CLEANSING PAD- benzocaine, alcohol cloth

  • NDC Code(s): 50814-080-00
  • Packager: GFA Production (Xiamen) Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2023

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  • DRUG FACTS

  • Active Ingredient:

    Benzocaine, 6% w/v

    SD Alcohol, 60% w/v

    Purpose:

    Topical Anesthetic

    Antiseptic

  • Use:

    For the temporary relief of pain and itching associated with minor burns scrapes and insect bites.

  • Warnings:

    For external use only.

    Do not use:

    In eyes, on broken skin, deep puncture wounds. If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.

    Keep out of reach of children.

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

    Flammable - keep away from fire or flame.

    Avoid contact with eyes. If this happens, rinse thoroughly with water.

  • 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: consult a doctor.

  • Inactive ingredient:

    Purified water.

  • Package Labeling:

    Label
  • INGREDIENTS AND APPEARANCE
    GENUINE FIRST AID ALCOHOL CLEANSING PAD 
    benzocaine, alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50814-080
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE60 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL600 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50814-080-000.225 mL in 1 POUCH; Type 0: Not a Combination Product01/11/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/11/2023
    Labeler - GFA Production (Xiamen) Co., Ltd. (421256261)