Label: INSECT STING RELIEF- benzocaine, alcohol swab

  • NDC Code(s): 50814-041-01, 50814-041-02, 50814-041-03
  • Packager: GFA Production (Xiamen) Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 25, 2023

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  • DRUG FACTS - Insect Sting Relief Pad

  • Active Ingredient:

    Benzocaine, 6% w/v

    SD alcohol, 60% w/v 

    Purpose:

    Topical Anesthetic

    Anesthetic

  • 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 unsual 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 Contrl Center right away.

    Flammable - keep away from fire or flame. Avoid contact with eyes. If this happens, rinse thoroughly with water

  • DOSAGE & ADMINISTRATION

  • Inactive Ingredients:

    Purified water.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    INSECT STING RELIEF 
    benzocaine, alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50814-041
    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:50814-041-010.18 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/29/2018
    2NDC:50814-041-020.53 mL in 1 POUCH; Type 0: Not a Combination Product06/29/2018
    3NDC:50814-041-030.225 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)01/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/29/2018
    Labeler - GFA Production (Xiamen) Co., Ltd. (421256261)
    Establishment
    NameAddressID/FEIBusiness Operations
    GFA Production (Xiamen) Co., Ltd.421256261manufacture(50814-041)
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