Label: CREST COMPLETE DEEP CLEAN- 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 June 29, 2018

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  • ACTIVE INGREDIENT

    Sodium fluoride .243%

  • PURPOSE

    Anticavity toothpaste

  • INDICATIONS & USAGE

    Help protect against cavities

  • KEEP OUT OF REACH OF CHILDREN

    Keep out reach of children under 6 Yrs of age. If more than used fro brushong is accidentally swallowed get medical help or poison control center right away

  • DOSAGE & ADMINISTRATION

    Direccions

    • adults and children 5 yrs and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
    • do not swallow
    • to minimiza swallowing use a pea-sized amount in children under 63
    • supervise children's brushing until good habits are established
    • children under 2 years as a dentist
  • INACTIVE INGREDIENT

    sorbitol,water,hydrated silica, PED-6, sodium lauryl sulfate, flavor,zinc citrate,cellulose gum,carrageenan, soium saccharin, hydroxyethlcellulose,sodium citrate, stannoum chloride,chloride,polyyethylene,titanium dioxide,blue 1 lake

  • WARNINGS

    Keep out of reach of children under 6 years

  • PRINCIPAL DISPLAY PANEL

    CREST COMPLETE

  • INGREDIENTS AND APPEARANCE
    CREST COMPLETE DEEP CLEAN 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69772-819
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.43 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    STANNOUS CHLORIDE (UNII: 1BQV3749L5)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Product Characteristics
    Colorwhite (With blue stripe and specs) Score    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69772-819-011 in 1 CARTON06/22/2015
    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 finalpart35506/22/2015
    Labeler - Teresa Cecena DBA Genesis (078760958)
    Registrant - Teresa Cecena (078760958)
    Establishment
    NameAddressID/FEIBusiness Operations
    Teresa Cecena DBA Genesis078760958relabel(69772-819)
    Establishment
    NameAddressID/FEIBusiness Operations
    Procter & Gamble Manufacturera S de RL de CV812807550manufacture(69772-819)
    Establishment
    NameAddressID/FEIBusiness Operations
    ROIR SA DE CV812825434relabel(69772-819)
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