Label: CREST GUM AND ENAMEL REPAIR INTENSIVE CLEAN- stannous fluoride paste, dentifrice

  • NDC Code(s): 37000-505-28, 37000-505-41, 37000-505-85
  • 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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  • 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, sodium gluconate, carrageenan, flavor, xanthan gum, zinc citrate, stannous chloride, sodium saccharin, sodium hydroxide, sucralose, titanium dioxide

  • Questions?

    1-800-492-7378

  • SPL UNCLASSIFIED SECTION

    DISTR. BY PROCTER & GAMBLE,

    CINCINNATI, OH 45202

  • Principal Display Panel - 116 g tube in carton

    Crest®

    FLUORIDE TOOTHPASTE FOR

    ANTICAVITY AND ANTIGINGIVITIS

    Gum

    &

    ENAMEL

    REPAIR
    INTENSIVE CLEAN

    Clinically Proven to help
    Reverse Gingivitis.
    Repairs Weakened Enamel.

    NET WT 4.1 OZ (116 g)

    505

  • INGREDIENTS AND APPEARANCE
    CREST GUM AND ENAMEL REPAIR  INTENSIVE CLEAN
    stannous fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-505
    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
    ZINC CITRATE (UNII: K72I3DEX9B)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    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)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-505-411 in 1 CARTON04/01/2018
    1116 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:37000-505-851 in 1 CARTON04/01/2018
    224 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:37000-505-281 in 1 CARTON04/01/2018
    379 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02104/01/2018
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Specialty Chemicals Seelze GmbH332940501api manufacture(37000-505)
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