CVS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [CVS PHARMACY]

CVS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [CVS PHARMACY]
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NDC 59779-123-19
Set ID 8691d6b6-741e-47b2-8332-76742b34715f
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
Generic Name
Product Class
Product Number
Application Number PART333B
  • 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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