Label: CREST PREMIUM PLUS ANTI-BACTERIAL- stannous fluoride paste, dentifrice

  • NDC Code(s): 37000-992-52, 37000-992-70
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 11, 2024

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  • SPL UNCLASSIFIED SECTION

    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
  • Warnings

    Keep out of reach of children. 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. & 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.: 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
    • this Crest is specially formulated to help prevent staining
    • see your dentist regularly
  • Inactive ingredients

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

  • Questions?

    1-800-594-4158

  • SPL UNCLASSIFIED SECTION

    DISTR. BY PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 144 g Tube Carton

    Crest ® plus PREMIUM

    FLUORIDE TOOTHPASTE FOR ANTICAVITY AND ANTIGINGIVITIS

    NET WT 7.0 OZ (198 g)

    ACTIVE FOAM +WHITENING

    ANTI-BACTERIAL

    HELPS KILL PLAQUE BACTERIA*

    smooth peppermint

    Label

  • INGREDIENTS AND APPEARANCE
    CREST PREMIUM PLUS  ANTI-BACTERIAL
    stannous fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-992
    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
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STANNOUS CHLORIDE (UNII: 1BQV3749L5)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-992-701 in 1 CARTON12/31/2020
    1198 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:37000-992-521 in 1 CARTON12/31/202007/12/2023
    2147 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02112/31/2020
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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