Label: CVS PHARMACY PRO DEFENSE- fluoride 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 May 15, 2023

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  • ACTIVE INGREDIENT

    Active ingredient

    Stannous Fluoride (0.454% w/w)

  • PURPOSE

    Purpose

    Anticavity/Antigingiviitis

  • INDICATIONS & USAGE

    Uses

    • aids in the prevention of dental cavities
    • helps control bleeding gums
    • helps interfere with harmful effects of plaque associated with gingivitis
  • WARNINGS

    Warnings

    When using this product, discontinue use if irritation occurs.

    Stop use and ask a dentist if

    • gingivitis, bleeding or redness persists for more than 2 weeks
    • if you have painful or swollen gums, pus from the gum line, loose teeth or increasing space between teeth. These may be signs or symptoms of periodontis, a serious form of gum disease.

    Keep out of reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 2 years of age and older:

    • Brush teeth thoroughly preferably after each meal or at least twice a day and not more than 3 times a day or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.
    • To minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing until good habits are established.

    Children under 2 years of age: consult a dentist or doctor

  • OTHER SAFETY INFORMATION

    Other information

    • products containing Stannous Fluoride may cause surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent, and may be removed by your dentist.
    • This product is specially formulated to help prevent staining.
    • Store below 77F (25C)
    • Keep tube capped when not in use.
  • INACTIVE INGREDIENT

    Inactive ingredients glycerin, water, hydrated silica, pentasodium triphosphate, cellulose gum, cocamidopropyl betaine, titanium dioxide, sodium lauryl sulfate, flavor, sodium saccharin

  • SPL UNCLASSIFIED SECTION

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    ©2017 CVS/pharmacy

    CVS.com 1-800-SHOP CVS

  • PRINCIPAL DISPLAY PANEL

    Carton Label

  • INGREDIENTS AND APPEARANCE
    CVS PHARMACY  PRO DEFENSE
    fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-872
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.454 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-872-191 in 1 CARTON06/01/201708/31/2024
    196.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/01/2017
    Labeler - CVS Pharmacy (062312574)
    Registrant - Lornamead Inc. (078584069)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Inc.080046418manufacture(69842-872)
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