Label: CREST GUM DETOXIFY- stannous fluoride paste, dentifrice

  • NDC Code(s): 37000-481-01, 37000-481-28, 37000-481-41, 37000-481-52, view more
    37000-481-82
  • 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 April 17, 2023

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  • Drug Facts

    Active ingredient

    Stannous fluoride 0.454%

    (0.14% 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
  • KEEP OUT OF REACH OF CHILDREN

  • 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

    • this Crest is specially formulated to help prevent staining
    • see your dentist regularly
  • Inactive ingredients

    water, sorbitol, hydrated silica, sodium lauryl sulfate, carrageenan, sodium gluconate, flavor, xanthan gum, zinc citrate, stannous chloride, sodium saccharin, sodium hydroxide, sucralose, titanium dioxide

  • Questions?

    1-800-594-4158

  • SPL UNCLASSIFIED SECTION

    DISTR. BY PROCTER & GAMBLE,

    CINCINNATI, OH 45202

  • Principal Display Panel - 24 g tube in carton


    Crest®

    Gum

    Detoxify®


    FLUORIDE TOOTHPASTE FOR

    ANTICAVITY AND ANTIGINGIVITIS

    Neutralizes plaque bacteria,
    even around the gum line

    DEEP CLEAN

    NET WT 0.85 OZ (24 g)

    694

  • INGREDIENTS AND APPEARANCE
    CREST  GUM DETOXIFY
    stannous fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-481
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    STANNOUS CHLORIDE (UNII: 1BQV3749L5)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorSPEARMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-481-011 in 1 CARTON08/01/2017
    124 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:37000-481-411 in 1 CARTON01/29/2018
    2116 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:37000-481-822 in 1 CELLO PACK08/01/2017
    31 in 1 CARTON
    3116 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:37000-481-281 in 1 CARTON02/03/2020
    479 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:37000-481-521 in 1 CARTON02/03/2020
    5147 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35508/01/2017
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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