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

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CVS PHARMACY MAXIMUM STRENGTH (BENZOCAINE) GEL, DENTIFRICE [CVS PHARMACY]
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NDC 59779-582-09
Set ID 92747826-cf58-4406-b3b5-12f7c7077c2c
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
Generic Name
Product Class
Product Number
Application Number PART333B
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  • Active ingredient

    Benzocaine 20%

  • Purpose

    Oral anesthetic

  • Use

    temporarily relieves pain associated with mouth and gum irritations

  • 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

    Stop use and ask a dentist or doctor if

    • sore mouth symptoms do not get better in 7 days
    • irritation, pain or redness persists or worsens
    • swelling, rash or fever develops

    When using this product

    • avoid contact with eyes.
    • do not exceed recommended dosage.
    • do not use for more than 7 days unless directed by doctor / dentist

    Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • to open tube, cut tip of tube on score mark.
    • adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by dentist/doctor.
    • children under 12 years of age: adult supervision should be given in the use of this product.
    • children under 2 years of age: consult a doctor / dentist.
    • for denture irritation apply a thin layer to the affected area; do not reinsert dental work intil irritation/pain is relieved; rinse mouth well after reinserting
  • Other Information

    Store at 20-25C (68-77F). Do not refrigerate

  • Inactive ingredients

    Blue 1, Carbomer, Flavor, Glycerin, Polyethylene Glycol, Propylene Glycol, Red 40, Sodium Saccharin, Sorbic Acid, Water, Yellow 10

  • PRINCIPAL DISPLAY PANEL

    Card R5

  • INGREDIENTS AND APPEARANCE
    CVS PHARMACY  MAXIMUM STRENGTH
    benzocaine gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-582
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBIC ACID (UNII: X045WJ989B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (Characteristic Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-582-091 in 1 CARTON01/20/2011
    19 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/20/2011
    Labeler - CVS Pharmacy (062312574)
    Registrant - Lornamead (126440440)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Inc.080046418manufacture(59779-582)
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