Label: PEPSODENT COMPLETE CARE ENAMEL-SAFE WHITENING- sodium fluoride paste, dentifrice

  • NDC Code(s): 10237-650-55, 10237-650-60
  • Packager: Church & Dwight Co., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 21, 2024

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

  • ACTIVE INGREDIENT

    Active ingredients     

    Sodium fluoride (0.24%)

  • PURPOSE

    Purpose
    Anticavity toothpaste

  • INDICATIONS & USAGE

    Use  aids in the prevention of dental decay

  • KEEP OUT OF REACH OF CHILDREN

    Warnings
    Keep out of reach of children under 6 years of age
    .

  • WARNINGS

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions   do not swallow    supervise children as necessary until capable of using without supervision

    adults and children 2 years and older               brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician
    children under 6 years                                    instruct in good brushing and rinsing habits (to minimize swallowing)
    children under 2 years                                    ask a dentist or physician

  • INACTIVE INGREDIENT

    Inactive ingredients  sorbitol, water, hydrated silica, PEG-32, sodium lauryl sulfate, SD alcohol 38-B, flavor, cellulose gum, zinc citrate trihydrate, sodium saccharin, titanium dioxide.

  • QUESTIONS

    Questions or comments?  Call 1-800-786-5135Monday-Friday 9am-5pm ET

  • Principal Display Panel

    Complete Protection For STRONGEnamel and HEALTHYGums

    Pepsodent Complete Care

    Enamel-Safe Whitening


    Controls Tartar Strengthens Enamel


    Anticavity Fluoride Toothpaste

    Smooth Mint Flavor


    NET WT. 6 OZ. (170g)

    CR2_DA1097754

  • INGREDIENTS AND APPEARANCE
    PEPSODENT COMPLETE CARE  ENAMEL-SAFE WHITENING
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-650
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    PEG-32 STEARATE (UNII: 33GX5WQC0M)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    ALCOHOL (UNII: 3K9958V90M)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINT (Smooth Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-650-601 in 1 CARTON03/01/200410/10/2019
    1170 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10237-650-551 in 1 CARTON03/01/200412/31/2024
    2156 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02103/01/2004
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Co., Inc.043690812manufacture(10237-650)