Label: ORAL GEL MAXIMUM STRENGTH- benzocaine gel

  • 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 January 16, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient
    Benzocaine 20%
  • PURPOSE

    Purpose
    Anesthetic
  • INDICATIONS & USAGE

    Uses for the temporary relief of pain associated with:
    • toothache  
    • canker sores  
    • cold sores  
    • fever blisters  
    • minor dental procedures
  • WARNINGS

    Warnings
    • do not use for more than 7 days unless directed by a dentist or a doctor
    • if you have a history of allergy to local anesthetics such as procaine, butacaine or other "caine" anesthetics
  • WHEN USING

    When using this product
    • avoid contact with the eyes  
    • do not exceed recommended dosage
  • STOP USE

    Stop using and ask a doctor
    • sore mouth symptoms do not improve in 7 days
    • swelling, rash or fever develops
    • irritation, pain or redness persists or worsens
  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
  • DOSAGE & ADMINISTRATION

    Directions adults and children 2 years of age and older:
    • cut open tip of tube
    • apply to the affected area up to 4 times daily or as directed by a dentist or doctor
    • children under 12 years of age should be supervised in the use of the product
    • children under 2 years of age, there is no recommended dosage except under the advice and supervision of a dentist or a doctor
  • SPL UNCLASSIFIED SECTION

    Other information
    • store at room temperature
    • Lot No. and Exp. Date: see box or see crimp of tube
  • INACTIVE INGREDIENT

    Inactive Ingredients Purified water, Glycerin, Propylene Glycol, Hydroxyethylcellulose, Carbomer, Sorbic Acid, Methylparaben, Propylparaben, FDC Yellow 5, FDC Red 40
  • PRINCIPAL DISPLAY PANEL

    Package Label
    image of package label

  • INGREDIENTS AND APPEARANCE
    ORAL GEL  MAXIMUM STRENGTH
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBIC ACID (UNII: X045WJ989B)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27293-012-011 in 1 BOX
    1NDC:27293-012-1414 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35602/01/2010
    Labeler - Budpak Inc. (183224849)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ausmetics Daily Chemicals (Guangzhou) Co. Ltd.529836561manufacture
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