Label: CREST TARTAR PROTECTION FRESH MINT GEL- sodium fluoride gel, dentifrice

  • NDC Code(s): 37000-009-06, 37000-009-24, 37000-009-57
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 17, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium fluoride 0.243% (0.15% w/v fluoride ion)

  • Purpose

    Anticavity toothpaste

  • Use

    helps protect against cavities

  • Warning

    Keep out of reach of children under 6 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 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
      • do not swallow
      • to minimize swallowing use a pea-sized amount in children under 6
      • supervise children's brushing until good habits are established
    • children under 2 yrs.: ask a dentist
  • Inactive ingredients

    sorbitol, water, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, sodium hydroxide, flavor, xanthan gum, sodium saccharin,cellulose gum, carbomer, blue 1

  • Questions?

    1-800-492-7378

  • SPL UNCLASSIFIED SECTION

    Dist. by Procter & Gamble, Cincinnati, OH 45202

  • PRINCIPAL DISPLAY PANEL - 161 g Carton

    HELPS PREVENT TARTAR & CAVITIES

    Crest®

    ADA
    Accepted
    American
    Dental
    Association ®

    FLUORIDE ANTICAVITY TOOTHPASTE

    NET WT 5.7 OZ (161 g)

    TARTAR
    PROTECTION

    Fresh Mint Gel

    009

  • INGREDIENTS AND APPEARANCE
    CREST TARTAR PROTECTION  FRESH MINT GEL
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-009
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-009-061 in 1 CARTON06/16/1995
    1181 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:37000-009-571 in 1 CARTON06/16/1995
    2161 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:37000-009-241 in 1 CARTON10/01/2021
    368 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02106/16/1995
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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