Label: CREST BE INSPIRED- sodium fluoride paste, dentifrice

  • NDC Code(s): 37000-847-04
  • 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 December 3, 2013

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% (0.15% w/v fluoride ion)

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  • Purpose

    Anticavity toothpaste

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  • Use

    helps protect against cavities

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  • Warning

    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, flavor, sodium lauryl sulfate, sodium saccharin, sodium hydroxide, carbomer, xanthan gum, cellulose gum, polyethylene, titanium dioxide, yellow 10 lake

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  • Questions?

    1-800-492-7378

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  • SPL UNCLASSIFIED SECTION

    Dist. by Procter & Gamble, Cincinnati, OH 45202

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  • PRINCIPAL DISPLAY PANEL - 127 g Tube Carton

    Crest®

    Be INSPIRED
    VANILLA MINT SPARK

    FLUORIDE TOOTHPASTE

    NET WT
    4.5 OZ (127 g)

    Principal Display Panel - 127 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    CREST   BE INSPIRED
    sodium fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-847
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 1.5 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)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Product Characteristics
    Color WHITE (with yellow specks) Score     
    Shape Size
    Flavor PEPPERMINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37000-847-04 1 in 1 CARTON
    1 127 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part355 01/06/2014
    Labeler - Procter & Gamble Manufacturing Company (004238200)
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