Label: CREST 3D WHITE BRILLIANCE PRO ENAMEL PROTECT- sodium fluoride paste, dentifrice

  • NDC Code(s): 69423-750-03, 69423-750-20
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 26, 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, sodium lauryl sulfate, carrageenan, cocamidopropyl betaine, trisodium phosphate, sodium saccharin, xanthan gum, sucralose, mica, titanium dioxide

  • Questions?

    1-800-492-7378

  • SPL UNCLASSIFIED SECTION

    Dist. by Procter & Gamble,
    Cincinnati, OH 45202

  • PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

    Crest

    3D WHITE

    FLUORIDE ANTICAVITY TOOTHPASTE

    NET WT 3.0 OZ (85 g)

    BRILLIANCE

    WHITER TEETH IN 3 DAYS

    100% MORE STAIN REMOVAL*

    ENAMEL PROTECT

    CLINICALLY PROVEN

    PRO WHITENING INGREDIENTS

    ENAMEL SAFE

    POA69423

  • INGREDIENTS AND APPEARANCE
    CREST 3D WHITE BRILLIANCE  PRO ENAMEL PROTECT
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-750
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    MICA (UNII: V8A1AW0880)  
    Product Characteristics
    Colorwhite (w/teal gel stripe) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-750-031 in 1 CARTON01/26/2023
    185 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69423-750-203 in 1 CELLO PACK01/26/2023
    21 in 1 CARTON
    285 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02101/26/2023
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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