Label: CREST- sodium fluoride paste, dentifrice

  • 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 May 3, 2021

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  • 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

    water, sorbitol, hydrated silica, disodium pyrophosphate, xylitol, flavor, sodium hydroxide, cellulose gum, cocamidopropyl betaine, sodium laureth-2 phosphate, sodium saccharin, xanthan gum, carbomer, sucralose, polyethylene oxide, polyethylene, mica, titanium dioxide, blue 1 lake

  • Questions?

    1-800-959-6586

  • SPL UNCLASSIFIED SECTION

    Dist. by Procter & Gamble, Cincinnati, OH 45202

  • Package Labeling

    crest24g

    Kit Package:

    kit package

  • INGREDIENTS AND APPEARANCE
    CREST 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69491-831
    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
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURETH-2 PHOSPHATE (UNII: 1IO8CC3XDG)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    POLYETHYLENE OXIDE 900000 (UNII: 16P9295IIL)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69491-831-011 in 1 CARTON12/23/2014
    124 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35512/23/2014
    Labeler - Buzz Export Services Pty., Ltd. (747317902)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Baron Travel Product Co., Ltd.554520509repack(69491-831)
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