Label: CVS PHARMACY MAXIMUM STRENGTH- benzocaine gel, dentifrice

  • 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 26, 2023

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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 (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Inc.080046418manufacture(59779-582)
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