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

  • NDC Code(s): 37000-853-04, 37000-853-08, 37000-853-83, 37000-853-85
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 13, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium fluoride 0.243% (0.15% w/v fluoride ion)

  • Purpose

    Anticavity toothpaste

  • Use

    helps protect against cavities

  • 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.

  • 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
  • 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, yellow 10 lake, iron oxides

  • Questions?

    1-800-492-7378

  • SPL UNCLASSIFIED SECTION

    Dist. by Procter & Gamble,
    Cincinnati, OH 45202

  • PRINCIPAL DISPLAY PANEL - 116 g Tube Carton

    Crest®
    3D WHITE ®
    FLUORIDE ANTICAVITY TOOTHPASTE
    WITH ILLUMINATING COMPLEX

    NET WT 4.1 OZ (116 g)

    OUR MOST ADVANCED WHITENING
    MEETS ADVANCED FRESHNESS

    BRILLIANCE

    WHITER, DAZZLING SMILE

    ENAMEL SAFE WHITENING
    MESMERIZING MINT

    Principal Display Panel - 116 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    CREST 3D WHITE 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-853
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 GLYCOL 900000 (UNII: 16P9295IIL)  
    POLYETHYLENE GLYCOL 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)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Product Characteristics
    Colorwhite (w/teal gel stripe) Score    
    ShapeSize
    FlavorSPEARMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-853-041 in 1 CARTON02/04/2014
    1116 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:37000-853-082 in 1 CELLO PACK02/04/2014
    21 in 1 CARTON
    2116 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:37000-853-851 in 1 CARTON02/04/2014
    324 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:37000-853-833 in 1 CELLO PACK02/04/201406/19/2019
    41 in 1 CARTON
    4116 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02102/04/2014
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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