Label: CVS MAXIMUM STRENGTH- benzocaine paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 26, 2023

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  • Active ingredient

    Benzocaine 20%

  • Purpose

    Oral pain reliever

  • Use

    for the temporary relief of pain due to

    • canker sores
    • cold sores
    • fever blisters
    • minor irritation of the mouth and gums caused by dentures or orthodontic appliances
  • Warnings

    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

    • avoid contact with the eyes
    • do not use more than directed
    • do not use for more than 7 days unless directed by a dentist or doctor.

    Stop use and ask a doctor if

    • 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. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • cut open tip of tube on scoremark
    • adults and children 2 years of age and older: 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 this product.
    • children under 2 years of age: ask a dentist or doctor.
    • for denture irritation apply a thin layer to the affected area; do not reinsert dental work until irritation/pain is relieved; rinse mouth well after reinserting
  • Other Information

    Do not use if tip is cut prior to opening. This preparation is intended for use in cases of toothache, only as a tempory expedient until a dentist can be consulted. Do not use continuously. This formula will stay in place for extended duration of relief.

  • Inactive ingredients

    Cellulose Gum, Gelatin, Menthol, Methyl Salicylate, Pectin, Petrolatum, Polyethylene Glycol, Sodium Saccharin.

  • PRINCIPAL DISPLAY PANEL

    Carton R6

  • INGREDIENTS AND APPEARANCE
    CVS   MAXIMUM STRENGTH
    benzocaine paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-123
    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
    MENTHOL (UNII: L7T10EIP3A)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    SACCHARIN (UNII: FST467XS7D)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    PECTIN (UNII: 89NA02M4RX)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorWINTERGREEN (L Menthol) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-123-191 in 1 CARTON01/20/2011
    112 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34801/20/2011
    Labeler - CVS Pharmacy (062312574)
    Registrant - Lornamead Inc. (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Inc.080046418manufacture(59779-123)
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