Label: CREST ANTI-CAVITY- 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 March 31, 2017

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    Sodium fluoride .243% (.15% w/v flouride ion)

  • PURPOSE

    Purpose

    Anticavity toothpaste

  • WARNINGS AND PRECAUTIONS

    WARNINGS AND PRECAUTIONS

    kEEEP OUT OF REACH OF CHILDREN UNDER 6 YRS OF AGE

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF THE CHILDREN UNDER 6 YRS OF AGE.

    If more than used for brishing is accidentally swallowed, get medical help or contact a poison control center rigth away.

  • DOSAGE & ADMINISTRATION

    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-sides amount in children under 6
    • supervise children's brushiong until goog habits are established
    • children under 2 yrs ask a dentist
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:

    sorbitol,water,hydrated silica, sodium lauryl sulfate, trisosium phosphate, flavor, sodium phospahte, cellulose gum, sodium saccharin, carbomer, titanium dioxide

  • INDICATIONS & USAGE

    USE

    Helps protect against cavities

  • WARNINGS

    KEEP OUT OF REACH OF CHILDREN UNDER 6 YTS OF AGE

  • PRINCIPAL DISPLAY PANEL

    C REST ANTI-CAVITY

  • INGREDIENTS AND APPEARANCE
    CREST ANTI-CAVITY 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69772-130
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.45 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    EUGENOL (UNII: 3T8H1794QW)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69772-130-011 in 1 CARTON03/31/2017
    1100 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35503/31/2017
    Labeler - GENESIS IMPORTS & EXPORTS LLC (078760958)
    Registrant - GENESIS IMPORTS & EXPORTS LLC (078760958)
    Establishment
    NameAddressID/FEIBusiness Operations
    genesis imports & exports llc078760958relabel(69772-130)
    Establishment
    NameAddressID/FEIBusiness Operations
    Procter & Gamble Manufactura, S. de R.L. de C.V.812807550manufacture(69772-130)
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