Label: CREST EXPRESSIONS SCOPE- 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 January 28, 2016

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    Sodium Fluoride

  • PURPOSE

    PURPOSE

    Anticavity toothpaste

  • WARNINGS

    WARNINGS

    kEEP OUT OF REACH OF CHILDREN UNDER 6 YRS OF AGE.IF MORE THAT USED FOR BRUSHING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL VENTER RIGHT AWAY.

  • INDICATIONS & USAGE

    DIRECTIONS

    • Adults and children 2 yrs. & older; brush teeth thoroughly after meals or at least twice a day or use as directed 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 INGREDIENT

    sorbitol,water,hydrated silica,disodium pyrophosphate, sodium lauryl sulfate, flavor, sodium hydroxide, alcohol, xanthan gum, sodium saccharin , glycerin, carbomer, cellulose gum, polysorbate 80, sodium benzoate, cethylpyridinium chloride, benzoic acid, titanium dioxide, blue 1, yellow 5

  • QUESTIONS

    QUESTIONS?

    1-800-492-7378

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS

  • DOSAGE & ADMINISTRATION

    DIRECTION

    Adults and childreen 2 yrs and older ; brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist

  • PRINCIPAL DISPLAY PANEL

    CREST EXPRESSIONS

  • INGREDIENTS AND APPEARANCE
    CREST EXPRESSIONS SCOPE 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69772-820
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION243 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    ALCOHOL (UNII: 3K9958V90M)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69772-820-01100 g in 1 TUBE; Type 0: Not a Combination Product01/28/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/28/2016
    Labeler - Teresa Cecena DBA Genesis Imports (078760958)
    Registrant - Teresa Cecena (078760958)
    Establishment
    NameAddressID/FEIBusiness Operations
    Teresa Cecena DBA Genesis078760958relabel(69772-820)
    Establishment
    NameAddressID/FEIBusiness Operations
    procter & gamble manufactura s. de r.l. de cv812807550manufacture(69772-820)
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