Label: CREST 3D WHITE ENAMEL RENEWAL- sodium fluoride paste, dentifrice

  • NDC Code(s): 37000-832-04, 37000-832-05
  • 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 May 7, 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% (0.15% w/v fluoride ion)

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  • Purpose

    Anticavity toothpaste

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  • Use

    helps protect against cavities

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  • 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

    water, sorbitol, hydrated silica, disodium pyrophosphate, xylitol, flavor, sodium hydroxide, cellulose gum, cocamidopropyl betaine, sodium laureth-2 phosphate, sodium saccharin, xanthan gum, carbomer, sucralose, polyethylene oxide, polyethylene, mica, titanium dioxide, blue 1 lake

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  • Questions?

    1-800-959-6586

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  • SPL UNCLASSIFIED SECTION

    Dist. by Procter & Gamble, Cincinnati, OH 45202

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  • PRINCIPAL DISPLAY PANEL - 116 g Tube Carton

    NEW

    Crest

    3D WHITE
    FLUORIDE ANTICAVITY
    TOOTHPASTE

    ENAMEL
    RENEWAL

    STRENGTHENS &
    REBUILDS WEAKENED
    ENAMEL

    REMOVES UP
    TO 90% OF
    SURFACE STAINS
    IN 7 DAYS

    P&G
    WORLDWIDE
    PARTNER

    ENAMEL SAFE
    WHITENING

    RENEWAL
    MINT

    NET WT
    4.1 OZ
    (116 g)

    Principal Display Panel - 116 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    CREST 3D WHITE   ENAMEL RENEWAL
    sodium fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-832
    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
    water (UNII: 059QF0KO0R)  
    sorbitol (UNII: 506T60A25R)  
    hydrated silica (UNII: Y6O7T4G8P9)  
    sodium acid pyrophosphate (UNII: H5WVD9LZUD)  
    xylitol (UNII: VCQ006KQ1E)  
    sodium hydroxide (UNII: 55X04QC32I)  
    carboxymethylcellulose sodium (UNII: K679OBS311)  
    cocamidopropyl betaine (UNII: 5OCF3O11KX)  
    saccharin sodium dihydrate (UNII: SB8ZUX40TY)  
    xanthan gum (UNII: TTV12P4NEE)  
    sucralose (UNII: 96K6UQ3ZD4)  
    polyethylene glycols (UNII: 3WJQ0SDW1A)  
    high density polyethylene (UNII: UG00KM4WR7)  
    mica (UNII: V8A1AW0880)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    FD&C blue no. 1 (UNII: H3R47K3TBD)  
    aluminum oxide (UNII: LMI26O6933)  
    Product Characteristics
    Color WHITE (with blue gel stripe) Score     
    Shape Size
    Flavor SPEARMINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37000-832-04 1 in 1 CARTON
    1 116 g in 1 TUBE
    2 NDC:37000-832-05 1 in 1 CARTON
    2 164 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part355 02/20/2012
    Labeler - Procter & Gamble Manufacturing Company (004238200)
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