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

  • NDC Code(s): 37000-400-03, 37000-400-04
  • 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 May 19, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium fluoride 0.243% (0.16% 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

    glycerin, hydrated silica, sodium hexametaphosphate, water, PEG-6, flavor, trisodium phosphate, sodium lauryl sulfate, carrageenan, cocamidopropyl betaine, sodium saccharin, sucralose, xanthan gum, titanium dioxide, mica

  • Questions?

    1-800-492-7378

  • SPL UNCLASSIFIED SECTION

    DISTR. BY
    PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 99 g Tube Carton

    Crest®
    3D WHITE

    LUXE™

    FLUORIDE ANTICAVITY

    TOOTHPASTE

    DIAMOND

    STRONG™

    REMOVES UP TO 90% OF SURFACE STAINS

    IN 3 DAYS & STRENGTHENS ENAMEL

    BRILLIANT MINT NET WT 3.5 OZ (99 g)

    400

  • INGREDIENTS AND APPEARANCE
    CREST 3D WHITE  LUXE DIAMOND STRONG
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-400
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    Product Characteristics
    Colorwhite (with blue gel stripe) Score    
    ShapeSize
    FlavorSPEARMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-400-031 in 1 CARTON09/01/2013
    199 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:37000-400-041 in 1 CARTON09/01/2013
    2136 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35509/01/2013
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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