Label: BENZOCAINE gel

  • NDC Code(s): 71888-101-01, 71888-101-02
  • Packager: Bellus Medical, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 8, 2023

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  • ACTIVE INGREDIENT

    Benzocaine 20%

  • INACTIVE INGREDIENT

    EthylAlcohol, PEG-8, Purified Water, Carbomer, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid

  • DOSAGE & ADMINISTRATION

    USES: For the temporary relief of discomfort and pain associated with

    • minor burns and skin irritations
    • minor cuts and scrapes
    • itching

    DIRECTIONS: Adults and children 12 years of age and older: Apply to affected area not more than 3-4 times daily.

  • WARNINGS

    For external use only. Avoid contact with the eyes.

    Stop use and ask a doctor if:

    • Skin becomes irritated
    • Condition worsens or symptoms last more than 7 days
    • Symptoms clear up and reoccur within a few days

    DO NOT USE: in large quantities, particularly over raw surfaces or blistered areas.

  • PURPOSE

    Topical Anesthetic

  • INDICATIONS & USAGE

    USES: For the temporary relief of discomfort and pain associated with

    • minor burns and skin irritations
    • minor cuts and scrapes
    • itching

    DIRECTIONS: Adults and children 12 years of age and older: Apply to affected area not more than 3-4 times daily.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PRINCIPAL DISPLAY PANEL

    BLT_4ml_Packet_B_170613

  • INGREDIENTS AND APPEARANCE
    BENZOCAINE 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71888-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SORBIC ACID (UNII: X045WJ989B)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71888-101-0212 in 1 BOX06/01/2017
    1NDC:71888-101-014 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/01/2017
    Labeler - Bellus Medical, LLC (005677967)
    Registrant - Bellus Medical, LLC (005677967)
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