CVS RAPID PROTECTION SENSITIVE (STANNOUS FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]

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CVS RAPID PROTECTION SENSITIVE (STANNOUS FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]
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NDC 69842-252-19
Set ID 8162fcc0-7a24-678c-e053-2a91aa0af2fe
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
Generic Name
Product Class
Product Number
Application Number PART356
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Stannous fluoride 0.454% (0.15% w/v fluoride ion)

  • PURPOSE

    Purpose

    Anticavity / Antihypersensitivity

  • INDICATIONS & USAGE

    Uses

    • aids in the prevention of dental cavities
    • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • WARNINGS

    Warnings

    When using this product, if irritation occurs discontinue use.

    Stop use and ask a dentist if:

    • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
    • pain/sensitivity still persists after 4 weeks of use

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

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush.

    • Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican.
    • Make sure to brush all sensitive areas of the teeth.
    • Do not swallow
    • Children under 12 years of age: consult a dentist or doctor
  • STORAGE AND HANDLING

    Other information

    products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed your dentist.

    • This product is specifically formulated to help prevent staining
    • store below 30°C (86°F)
  • INACTIVE INGREDIENT

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

  • SPL UNCLASSIFIED SECTION

    ** in 3 days with twice daily brushing based on laboratory study

    Distributed by:

    CVS Pharmacy, Inc.

    One CVS Drive

    Woonsocket, RI 02895

    CVS.com®

    1-800-SHOP CVS

  • PRINCIPAL DISPLAY PANEL

    CVS Health™

    RAPID PROTECTION

    SENSITIVE

    ANTICAVITY TOOTHPASTE WITH FLUORIDE

    Works quickly** to create a barrier over sensitive areas

    Extra Fresh

    NET WT 3.4 OZ (96.4 g)

    CVS_Sensitive_RapidProtection_Ctn_ F8015006

  • INGREDIENTS AND APPEARANCE
    CVS RAPID PROTECTION SENSITIVE 
    stannous fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-252
    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
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-252-191 in 1 CARTON02/07/2019
    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 not finalpart35602/07/2019
    Labeler - CVS Pharmacy (062312574)
    Registrant - Lornamead (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Inc.080046418manufacture(69842-252)
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