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

  • NDC Code(s): 69423-787-35, 69423-787-46, 69423-787-85
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 12, 2023

If you are a consumer or patient please visit this version.

  • 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

    glycerin, hydrated silica, sodium hexametaphosphate, water, PEG-6, flavor, sodium
    lauryl sulfate, cocamidopropyl betaine, trisodium phosphate, sodium saccharin, PVP, carrageenan, xanthan gum, sucralose, mica, titanium dioxide, red 40, blue 1

  • 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 Brilliance24 HR ACTIVE STAIN PREVENTION*

    CREST

    3D WHTE

    NET WT

    3.5 OZ (99 g)

    FLUORIDE ANTICAVITY TOOTHPASTE

    BRILLIANCE

    OUR PURPLE TOOTHPASTE REMOVES

    100% MORE STAINS**

    WHITER TEETH IN 3 DAYS

    LUMINOUS PURPLE

  • INGREDIENTS AND APPEARANCE
    CREST  3D WHITE BRILLIANCE LUMINOUS PURPLE
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-787
    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
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-787-851 in 1 CARTON06/15/2022
    124 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69423-787-461 in 1 CARTON06/15/2022
    2131 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:69423-787-351 in 1 CARTON06/15/2022
    399 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02106/15/2022
    Labeler - The Procter & Gamble Manufacturing Company (004238200)