Label: CREST 3D WHITE BRILLIANCE DAILY CLEANSING AND WHITENING SYSTEM- stannous fluoride kit

  • NDC Code(s): 37000-863-04
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 13, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Stannous fluoride 0.454% (0.15% w/v fluoride ion)

  • Purposes

    Anticavity, antigingivitis toothpaste

  • Uses

    • aids in the prevention of cavities
    • helps prevent gingivitis
    • helps interfere with the harmful effects of plaque associated with gingivitis
    • helps control plaque bacteria that contribute to the development of gingivitis
  • Warning

    Keep out of reach of children under 12 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 12 yrs. of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
    • do not swallow
    • children under 12 yrs. of age: ask a dentist
  • Other information

    • products containing stannous fluoride may produce surface staining of the teeth
    • adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist
    • see your dentist regularly
  • Inactive ingredients

    glycerin, hydrated silica, water, zinc lactate, sodium lauryl sulfate, trisodium phosphate, flavor, sodium gluconate, sodium saccharin, xanthan gum, cellulose gum, sodium hydroxide, mica, titanium dioxide

  • Questions?

    1 (800) 492-7378

  • SPL UNCLASSIFIED SECTION

    DISTR. BY PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    Crest®
    3D WHITE™

    FLUORIDE TOOTHPASTE FOR ANTICAVITY & ANTIGINGIVITIS | WHITENING GEL

    DAILY CLEANSING & WHITENING SYSTEM

    STEP
    1
    DEEP CLEANSING
    TOOTHPASTE

    STEP
    2
    WHITENING
    FINISHER

    BRILLIANCE

    DEEP CLEANS & KEEPS YOUR SMILE UP TO
    99% AS WHITE AS A PROFESSIONAL POLISH*

    1 TUBE NET WT 4.0 OZ (113 g) & 1 TUBE NET WT 2.3 OZ (65 g)

    97198780

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    CREST 3D WHITE BRILLIANCE  DAILY CLEANSING AND WHITENING SYSTEM
    stannous fluoride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-863
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-863-041 in 1 CARTON; Type 1: Convenience Kit of Co-Package02/05/2015
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 113 g
    Part 21 TUBE 65 g
    Part 1 of 2
    CREST 3D WHITE STEP 1  PURIFYING CLEANSER
    stannous fluoride paste, dentifrice
    Product Information
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    ZINC LACTATE (UNII: 2GXR25858Y)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02102/05/2015
    Part 2 of 2
    CREST 3D WHITE STEP 2  WHITENING GEL
    other oral hygiene products gel, dentifrice
    Product Information
    Route of AdministrationDENTAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRHYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    INGRSODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
    INGRSUCRALOSE (UNII: 96K6UQ3ZD4)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    165 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic02/05/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02102/05/2015
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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