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

  • NDC Code(s): 69423-792-01, 69423-792-02, 69423-792-24, 69423-792-46
  • 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 June 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, sodium lauryl sulfate, sodium hydroxide, flavor, cellulose gum, sodium saccharin, carbomer, charcoal powder, sucralose, polysorbate 80, mica, titanium dioxide

  • Questions?

    1-800-492-7378

  • SPL UNCLASSIFIED SECTION

    DISTR. BY PROCTER & GAMBLE, CINCINNATI, OH 45202

  • PDP - 68 g Carton

    Crest 3D White Whitening Therapy CharcoalTRAVEL FRIENDLY SIZE

    CREST

    3D WHITE

    FLUORIDE ANTICAVITY TOOTHPASTE

    WHITENING THERAPY

    CHARCOAL

    DEEP CLEAN

    INVIGORATING MINT

    NET WT 2.4 OZ (68g)

  • INGREDIENTS AND APPEARANCE
    CREST 3D WHITE WHITENING THERAPY CHARCOAL 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-792
    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)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    Product Characteristics
    ColorblackScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-792-241 in 1 CARTON01/01/2023
    168 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69423-792-461 in 1 CARTON01/01/2023
    2130 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:69423-792-013 in 1 CELLO PACK01/01/2023
    31 in 1 CARTON
    3130 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:69423-792-022 in 1 CELLO PACK01/01/2023
    41 in 1 CARTON
    4130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/01/2023
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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