Label: CREST PRO-HEALTH CLINICAL GUM PROTECTION- stannous fluoride paste, dentifrice

  • NDC Code(s): 37000-561-01, 37000-561-02, 37000-561-04, 37000-561-05, view more
    37000-561-07
  • Packager: Procter & Gamble Manufacturing Company
  • 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 January 22, 2015

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Stannous fluoride 0.454% (0.16% w/v fluoride ion)

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  • Purposes

    Anticavity, antigingivitis, antisensitivity toothpaste

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  • Uses

    • aids in the prevention of cavities
    • helps prevent gingivitis
    • helps interfere with the harmful effects of plaque associated with gingivitis
    • helps control plaque bacteria that contribute to the development of gingivitis
    • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
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  • Warnings

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

    Stop use and ask a dentist if the sensitivity problem persists or worsens. 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

    • adults and children 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 swallow
    • children under 12 yrs.: ask a dentist
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  • 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 by your dentist
    • this Crest is specially formulated to help prevent staining
    • see your dentist regularly
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  • Inactive ingredients

    glycerin, hydrated silica, sodium hexametaphosphate, propylene glycol, PEG-6, water, zinc lactate, flavor, trisodium phosphate, sodium gluconate, sodium lauryl sulfate, sodium saccharin, carrageenan, stannous chloride, xanthan gum, polyethylene, titanium dioxide, blue 1 lake, blue 1

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  • Questions?

    1-800-594-4158

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  • SPL UNCLASSIFIED SECTION

    Dist. by Procter & Gamble, Cincinnati, OH 45202

    www.crest.com

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  • PRINCIPAL DISPLAY PANEL - 164g Tube Carton

    NEW

    Crest®
    PRO-HEALTH®

    CAVITIES
    GINGIVITIS
    PLAQUE
    SENSITIVITY
    TARTAR
    WHITENING
    FRESHENS
    BREATH

    NET WT 5.8 OZ (164 g)
    FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH

    CLINICAL
    GUM
    PROTECTION

    Helps Prevent Gingivitis &
    Helps Reverse Gingivitis
    in 4 weeks

    CLEAN MINT

    Principal Display Panel - 164g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    CREST PRO-HEALTH   CLINICAL GUM PROTECTION
    stannous fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-561
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Stannous Fluoride (UNII: 3FTR44B32Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 1.6 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    glycerin (UNII: PDC6A3C0OX)  
    hydrated silica (UNII: Y6O7T4G8P9)  
    sodium polymetaphosphate (UNII: P1BM4ZH95L)  
    propylene glycol (UNII: 6DC9Q167V3)  
    polyethylene glycol 300 (UNII: 5655G9Y8AQ)  
    water (UNII: 059QF0KO0R)  
    zinc lactate (UNII: 2GXR25858Y)  
    sodium gluconate (UNII: R6Q3791S76)  
    sodium lauryl sulfate (UNII: 368GB5141J)  
    saccharin sodium (UNII: SB8ZUX40TY)  
    carrageenan (UNII: 5C69YCD2YJ)  
    stannous chloride (UNII: 1BQV3749L5)  
    xanthan gum (UNII: TTV12P4NEE)  
    high density polyethylene (UNII: UG00KM4WR7)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    fd&c blue no. 1 (UNII: H3R47K3TBD)  
    aluminum oxide (UNII: LMI26O6933)  
    Product Characteristics
    Color BLUE Score     
    Shape Size
    Flavor WINTERGREEN, PEPPERMINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37000-561-01 24 g in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:37000-561-02 1 in 1 CARTON
    2 24 g in 1 TUBE; Type 0: Not a Combination Product
    3 NDC:37000-561-04 1 in 1 CARTON
    3 113 g in 1 TUBE; Type 0: Not a Combination Product
    4 NDC:37000-561-05 1 in 1 CARTON
    4 164 g in 1 TUBE; Type 0: Not a Combination Product
    5 NDC:37000-561-07 1 in 1 CARTON
    5 218 g in 1 TUBE; Type 0: Not a Combination Product
    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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