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
  • 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 23, 2023

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  • 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 1-800-786-5135 Monday-Friday 9am-5pm ET

  • Principal Display Panel

    Complete Protection For STRONG Enamel and HEALTHY Gums

    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 CARTON03/01/2004
    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 finalpart35503/01/2004
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Co., Inc.043690812manufacture(10237-650)
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