Label: CREST 3D WHITE LUXE LUSTROUS SHINE- sodium fluoride paste, dentifrice

  • NDC Code(s): 37000-842-04, 37000-842-05
  • Packager: The 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 October 17, 2016

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

    water, sorbitol, hydrated silica, disodium pyrophosphate, xylitol, flavor, sodium hydroxide, cellulose gum, cocamidopropyl betaine, sodium laureth-2 phosphate, sodium saccharin, xanthan gum, carbomer, sucralose, PEG-20M or PEG-23M, polyethylene, mica, titanium dioxide, blue 1 lake

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  • Questions?

    1-800-492-7378

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  • SPL UNCLASSIFIED SECTION

    DISTR. BY
    PROCTER & GAMBLE,
    CINCINNATI, OH 45202

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  • PRINCIPAL DISPLAY PANEL - 156 g Tube Carton

    CREST®
    3DWHITE
    LUXE
    WHITELOCK™ TECHNOLOGY

    STRENGTHENS ENAMEL & REMOVES
    UP TO 90% OF SURFACE STAINS IN 1 WEEK

    DIAMOND STRONG™

    FLUORIDE ANTICAVITY TOOTHPASTE
    ENAMEL SAFE WHITENING

    BRILLIANT MINT
    NET WT 5.5 OZ (156 g)

    PRINCIPAL DISPLAY PANEL - 156 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    CREST 3D WHITE  LUXE LUSTROUS SHINE
    sodium fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-842
    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
    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)  
    SODIUM LAURETH-2 PHOSPHATE (UNII: 1IO8CC3XDG)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    POLYETHYLENE OXIDE 900000 (UNII: 16P9295IIL)  
    POLYETHYLENE OXIDE 1000000 (UNII: HZ58M6D839)  
    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:37000-842-04 1 in 1 CARTON 09/01/2013 12/05/2017
    1 116 g in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:37000-842-05 1 in 1 CARTON 09/01/2013 12/05/2017
    2 164 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 09/01/2013 12/05/2017
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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