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

  • 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 February 12, 2021

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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

    Dist. by Procter & Gamble,
    Cincinnati, OH 45202

  • PRINCIPAL DISPLAY PANEL - 99 g Tube Carton

    Crest®
    3D WHITE
    LUXE ®

    FLUORIDE ANTICAVITY
    TOOTHPASTE

    GLAMOROUS
    WHITE ®

    REMOVES UP TO 95% OF SURFACE STAINS
    IN 3 DAYS & PROTECTS AGAINST FUTURE STAINS



    VIBRANT MINT

    NET WT 3.5 OZ (99 g)

    852

  • INGREDIENTS AND APPEARANCE
    CREST 3D WHITE 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-852
    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)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-852-011 in 1 CARTON02/04/201407/12/2017
    124 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:37000-852-041 in 1 CARTON02/04/2014
    2116 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:37000-852-051 in 1 CARTON02/04/201407/12/2017
    3156 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:37000-852-351 in 1 CARTON02/04/2014
    499 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:37000-852-481 in 1 CARTON02/04/201406/19/2019
    5136 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:37000-852-072 in 1 CELLO PACK02/04/201406/19/2019
    61 in 1 CARTON
    699 g in 1 TUBE; Type 0: Not a Combination Product
    7NDC:37000-852-822 in 1 CELLO PACK02/04/2014
    71 in 1 CARTON
    7116 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35502/04/2014
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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