Label: CREST PRO-HEALTH HEALTHY FRESH- stannous fluoride paste, dentifrice

  • NDC Code(s): 37000-841-01, 37000-841-04, 37000-841-06, 37000-841-07
  • 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 April 24, 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, trisodium phosphate, flavor, sodium lauryl sulfate, sodium gluconate, carrageenan, sodium saccharin, xanthan gum, polyethylene, 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

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  • PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

    Crest
    PRO-HEALTH

    NET WT 6.0 OZ (170 g)
    FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH

    HEALTHY
    FRESH

    FIGHTS BAD BREATH
    FOR HOURS

    ONE TOOTHPASTE THAT DOES IT ALL:

     
    CAVITIES/ENAMEL
     
    GINGIVITIS
     
    PLAQUE
     
    SENSITIVITY
     
    TARTAR
     
    WHITENING
     
    FRESHENS BREATH

    COOL
    PEPPERMINT

    Principal Display Panel - 170 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    CREST PRO-HEALTH   HEALTHY FRESH
    stannous fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-841
    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 lauryl sulfate (UNII: 368GB5141J)  
    sodium gluconate (UNII: R6Q3791S76)  
    carrageenan (UNII: 5C69YCD2YJ)  
    saccharin sodium (UNII: SB8ZUX40TY)  
    xanthan gum (UNII: TTV12P4NEE)  
    high density polyethylene (UNII: UG00KM4WR7)  
    FD&C blue no. 1 (UNII: H3R47K3TBD)  
    aluminum oxide (UNII: LMI26O6933)  
    Product Characteristics
    Color BLUE (with blue specks) Score     
    Shape Size
    Flavor PEPPERMINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37000-841-01 1 in 1 CARTON
    1 24 g in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:37000-841-04 1 in 1 CARTON
    2 119 g in 1 TUBE; Type 0: Not a Combination Product
    3 NDC:37000-841-06 1 in 1 CARTON
    3 170 g in 1 TUBE; Type 0: Not a Combination Product
    4 NDC:37000-841-07 1 in 1 CARTON
    4 221 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 02/01/2013
    Labeler - Procter & Gamble Manufacturing Company (004238200)
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