Label: MOUTH SORE RELIEF PROFESSIONAL STRENGTH- benzocaine liquid 

  • Label RSS
  • NDC Code(s): 59779-830-31, 59779-830-38
  • Packager: CVS Pharmacy
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/11

If you are a consumer or patient please visit this version.

  • Active ingredient

    Benzocaine 20.0% (w/w) ...................................................................... Oral anesthetic/analgesic Close
  • Use

    for the temporary relief of pain due to canker sores, minor irritation of the mouth and
    gums caused by dentures or orthodontic appliances, or minor injury of the mouth or gums
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  • WARNINGS

    For oral use only

    Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as
    procaine, butacaine, benzocaine or other “caine” anesthetics

    When using this product • do not use for more than 7 days unless directed by a dentist or doctor.
    If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens;
    or if swelling, rash or fever develops, see your doctor or dentist promptly. Do not exceed
    recommended dosage.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center
    right away.

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  • Directions

    • to assure formation of long-lasting film coating, dry affected area and apply
    medication undiluted with applicator • allow a few seconds for coating to form
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  • Other Information

    • do not use if package has been opened
    • store at 20-25˚C (68-77°F)
    • close cap tightly after use to avoid evaporation
    • avoid contact with eyes
    • avoid contact with clothing and household/furniture surfaces to prevent possible staining
    • this is a personal care item, and should be used by one individual only Close
  • Inactive ingredients

    Benzyl Alcohol, Cetylpyridinium
    Chloride, Compound Benzoin Tincture,
    Dimethyl Isosorbide, Ethylcellulose,
    Flavor, Octylacrylamide/acrylates/
    butylaminoethyl/methacrylate
    Copolymer, Oleth-10, PEG-6, Propylene
    Glycol, Ricinus Communis (Castor)
    Seed Oil , SD Alcohol 38B, Sucralose,
    Tannic Acid. Close
  • DOSAGE & ADMINISTRATION

    • use 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 this product • children under 2 years of age: consult a dentist or doctor Close
  • INGREDIENTS AND APPEARANCE
    MOUTH SORE RELIEF  PROFESSIONAL STRENGTH
    benzocaine liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-830
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (BENZOCAINE) BENZOCAINE 200 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    MENTHOL 4.34 mg  in 1 g
    ALCOHOL 280.87 mg  in 1 g
    ETHYLCELLULOSES 0.1 mg  in 1 g
    TANNIC ACID 30 mg  in 1 g
    CETYLPYRIDINIUM CHLORIDE 0.5 mg  in 1 g
    SUCRALOSE 3 mg  in 1 g
    BENZYL ALCOHOL 1 mg  in 1 g
    PROPYLENE GLYCOL 50 mg  in 1 g
    OLETH-10 5 mg  in 1 g
    DIMETHYL ISOSORBIDE 5 mg  in 1 g
    RICINUS COMMUNIS SEED 2 mg  in 1 g
    WATER 14.78 mg  in 1 g
    POLYETHYLENE GLYCOL 300 338.5 mg  in 1 g
    BENZOIN 10 mg  in 1 g
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor MINT (Mint Flavor #25797) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-830-38 1 in 1 BLISTER PACK
    1 NDC:59779-830-31 14.7 g in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 10/01/2009
    Labeler - CVS Pharmacy (062312574)
    Registrant - Lornamead (126440440)
    Establishment
    Name Address ID/FEI Business Operations
    CSR Cosmetic Solutions 243501959 manufacture(59779-830), pack(59779-830)
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