Label: CREST PRO-HEALTH FOR ME- sodium fluoride paste, dentifrice

  • NDC Code(s): 37000-007-01, 37000-007-02, 37000-007-04, 37000-007-06
  • 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 9, 2012

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Sodium fluoride 0.243% (0.16% w/v fluoride ion)

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  • Purpose

    Anticavity toothpaste

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  • Use

    helps protect against cavities

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  • Warnings

    Keep out of reach of children under 6 yrs. of age. 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 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
      • do not swallow
      • to minimize swallowing use a pea-sized amount in children under 6
      • supervise children's brushing until good habits are established
    • children under 2 yrs.: ask a dentist
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  • Inactive ingredients

    sorbitol, water, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, sodium hydroxide, flavor, sodium saccharin, xanthan gum, carbomer, polyethylene, mica, titanium dioxide, blue 1 lake

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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 - 170 g Carton

    new

    Crest

    PRO-HEALTH
    FOR ME

    NET WT 6.0 OZ (170g)

    FLUORIDE ANTICAVITY TOOTHPASTE

    Designed for
    KIDS
    8 & Up

    FIGHTS CAVITIES
    & TARTAR

    STRENGTHENS
    ENAMEL

    FRESHENS BREATH

    WHITENS

    MINTY BREEZE

    Principal Display Panel - 170 g Carton
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  • INGREDIENTS AND APPEARANCE
    CREST PRO-HEALTH FOR ME 
    sodium fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-007
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride ion - UNII:Q80VPU408O) Sodium Fluoride 2.43 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    sorbitol (UNII: 506T60A25R)  
    water (UNII: 059QF0KO0R)  
    hydrated silica (UNII: Y6O7T4G8P9)  
    sodium acid pyrophosphate (UNII: H5WVD9LZUD)  
    sodium lauryl sulfate (UNII: 368GB5141J)  
    sodium hydroxide (UNII: 55X04QC32I)  
    saccharin sodium (UNII: SB8ZUX40TY)  
    xanthan gum (UNII: TTV12P4NEE)  
    mica (UNII: V8A1AW0880)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    FD&C blue no. 1 (UNII: H3R47K3TBD)  
    aluminum oxide (UNII: LMI26O6933)  
    Product Characteristics
    Color WHITE (Clear w/blue specs) Score     
    Shape Size
    Flavor PEPPERMINT, SPEARMINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37000-007-02 1 in 1 CARTON
    1 NDC:37000-007-01 24 g in 1 TUBE
    2 NDC:37000-007-04 1 in 1 CARTON
    2 119 g in 1 TUBE
    3 NDC:37000-007-06 1 in 1 CARTON
    3 170 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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