Label: CREST GUM DETOXIFY PLUS WHITENING- stannous fluoride kit

  • NDC Code(s): 37000-489-01
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 18, 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, polyethylene, mica, titanium dioxide, blue 1

  • Questions?

    (800) 492-7378

  • SPL UNCLASSIFIED SECTION

    Dist. by Procter & Gamble,
    Cincinnati, OH 45202

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    CLINICALLY PROVEN RESULTS IN ONE WEEK

    Crest®
    GUM DETOXIFY

    + WHITENING™

    FLUORIDE TOOTHPASTE FOR ANTICAVITY AND

    ANTIGINGIVITIS/WHITENING GEL

    STEP 1

    6X Gum health
    Improvement in one week*
    *gingivitis improvement vs. ordinary toothpaste

    STEP 2

    Whiter teeth
    in 1 week**
    **improvement vs. ordinary toothpaste

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

    489

  • INGREDIENTS AND APPEARANCE
    CREST GUM DETOXIFY  PLUS WHITENING
    stannous fluoride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-489
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-489-011 in 1 CARTON; Type 1: Convenience Kit of Co-Package01/01/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 113 g
    Part 21 TUBE 65 g
    Part 1 of 2
    CREST  GUM DETOXIFYING TREATMENT
    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
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    ZINC LACTATE (UNII: 2GXR25858Y)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorWINTERGREENImprint 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 DrugM02101/01/2018
    Part 2 of 2
    CREST  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)  
    INGRCARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    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
    Cosmetic01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02101/01/2018
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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