Label: CREST SENSITIVITY CLINICAL SENSITIVITY RELIEF- potassium nitrate and sodium fluoride paste, dentifrice

  • NDC Code(s): 37000-519-01, 37000-519-02, 37000-519-04
  • Packager: Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/11

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients Purpose
    Potassium nitrate 5% Toothpaste for sensitive teeth
    Sodium fluoride 0.243% Toothpaste for cavity prevention
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  • Uses

    • when used regularly, builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
    • aids in the prevention of cavities
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  • Warnings

    When using this product do not use longer than four weeks unless recommended by a dentist

    Stop use and ask a dentist if problem lasts or gets worse. Sensitive teeth may indicate a serious problem that may need prompt care.

    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.

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  • Directions

    • do not swallow
    • 12 yrs. & older: Apply at least a 1-inch strip of the product onto a soft bristled toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth.
    • do not use in children under 12 yrs.
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  • Inactive ingredients

    water, hydrated silica, glycerin, sorbitol, trisodium phosphate, sodium lauryl sulfate, flavor, cellulose gum, alcohol (1.09%), xanthan gum, sodium saccharin, polysorbate 80, sodium benzoate, cetylpyridinium chloride, benzoic acid, polyethylene, titanium dioxide, blue 1

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  • Questions?

    1-800-492-7378

    Dist. by Procter & Gamble,
    Cincinnati, OH 45202

    www.crest.com

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  • PRINCIPAL DISPLAY PANEL - 116 g Tube Carton

    Crest
    SENSITIVITY
    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    NET WT 4.1 OZ (116 g)
    CLINICALLY PROVEN SENSITIVITY INGREDIENT WITH FLUORIDE

    CLINICAL
    SENSITIVITY
    RELIEF

    MAXIMUM STRENGTH*

    EXTRA
    WHITENING

    CLEAN MINT

    Principal Display Panel
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  • INGREDIENTS AND APPEARANCE
    CREST SENSITIVITY   CLINICAL SENSITIVITY RELIEF
    potassium nitrate and sodium fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37000-519
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Potassium nitrate (POTASSIUM CATION) Potassium nitrate 0.05 g  in 1 g
    Sodium Fluoride (fluoride ion) Sodium Fluoride 243 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    water  
    hydrated silica  
    glycerin  
    sorbitol  
    sodium lauryl sulfate  
    Carboxymethylcellulose Sodium  
    alcohol  
    xanthan gum  
    saccharin sodium  
    polysorbate 80  
    sodium benzoate  
    cetylpyridinium chloride  
    benzoic acid  
    titanium dioxide  
    FD&C BLUE NO. 1  
    Product Characteristics
    Color BLUE (with white specks) Score     
    Shape Size
    Flavor PEPPERMINT, SPEARMINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37000-519-02 1 in 1 CARTON
    1 NDC:37000-519-01 24 g in 1 TUBE
    2 NDC:37000-519-04 1 in 1 CARTON
    2 116 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part355 08/30/2010
    Labeler - Procter & Gamble Manufacturing Company (004238200)
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