Label: CREST PURE ALL AROUND CLEAN- sodium fluoride paste, dentifrice

  • NDC Code(s): 37000-986-41
  • 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 June 11, 2021

If you are a consumer or patient please visit this version.

  • 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

  • Warnings

    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, cocamidopropyl betaine, cellulose gum, flavor, stevia rebaudiana extract, trisodium phosphate, sodium phosphate, xanthan gum

  • Questions?

    1-800-492-7378

  • PRINCIPAL DISPLAY PANEL - 116 g Tube Carton

    Crest ®

    pure™

    FLUORIDE ANTICAVITY TOOTHPASTE

    TRUSTED PROTECTION

    ALL AROUND CLEAN

    made without:

    artificial colors

    artificial flavors

    artificial sweeteners

    sodium lauryl sulfate

    titanium dioxide

    natural mint
    NET WT 4.1 OZ (116 g)

    986

  • INGREDIENTS AND APPEARANCE
    CREST PURE  ALL AROUND CLEAN
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-986
    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
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-986-411 in 1 CARTON12/31/2020
    1116 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35512/31/2020
    Labeler - The Procter & Gamble Manufacturing Company (004238200)