Label: BENZOCAINE,ISOPROPYL ALCOHOL swab

  • 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 December 21, 2021

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  • Drug Facts

  • Active Ingredient

    Benzocaine, 6% w/v

    Isopropyl Alcohol 60% w/v

  • Purpose

    Topical Anesthetic

    Antiseptic

  • Use

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

  • Warnings

    For external use only.

    Do not use

    • in the eyes If contact occurs, flush eyes with water.

    Flammable,

    keep away from fire or flame.

    Stop use and ask a doctor if

    irritation and redness develop

    Keep out of reach of children

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

  • Directions

    Apply to affected area 3-4 times daily. For adults and children 2 years of age and older. Children under 2 years; consult physician.

  • Inactive Ingredients

    purified water

  • PRINCIPAL DISPLAY PANEL

    Front Label

    Back Label

  • INGREDIENTS AND APPEARANCE
    BENZOCAINE,ISOPROPYL ALCOHOL 
    benzocaine,isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44224-3623
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE60 mg  in 1 mL
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.6 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44224-3623-00.4 mL in 1 POUCH; Type 0: Not a Combination Product01/03/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/03/2022
    Labeler - Adventure Ready Brands (064437304)
    Registrant - Adventure Ready Brands (064437304)
    Establishment
    NameAddressID/FEIBusiness Operations
    Adventure Ready Brands064437304manufacture(44224-3623)
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