Label: CLOSE UP WHITENING WITH MOUTHWASH- sodium fluoride gel, dentifrice

  • NDC Code(s): 10237-645-40, 10237-645-60
  • 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 June 12, 2012

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  • ACTIVE INGREDIENT

    Active ingredients        

    Sodium fluoride (0.24%)

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  • PURPOSE

    Purpose
    Anticavity toothpaste

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  • INDICATIONS & USAGE

    Use  aids in the prevention of dental decay
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  • KEEP OUT OF REACH OF CHILDREN

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

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  • WARNINGS

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

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  • 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

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  • INACTIVE INGREDIENT

    Inactive ingredients  sorbitol, water, hydrated silica, PEG-8, sodium lauryl sulfate, SD alcohol 38-B, flavor, cellulose gum, sodium saccharin, mica, red 33, red 40, titanium dioxide

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  • QUESTIONS

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

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  • PRINCIPAL DISPLAY PANEL

    ANTICAVITY FLUORIDE TOOTHPASTE

    CLOSE UP

    with
    Ultra Cinnamon
    Flavor Blast


    Cleans, Whitens and Freshens
    with Mouthwash

    WHITENING Gel

    NET WT. 4.0 OZ. (113.4g)

    Carton imageCarton image

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  • INGREDIENTS AND APPEARANCE
    CLOSE UP  WHITENING WITH MOUTHWASH
    sodium fluoride gel, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-645
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 2.4 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    ALCOHOL (UNII: 3K9958V90M)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color red Score     
    Shape Size
    Flavor CINNAMON (Cinnamint) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10237-645-60 1 in 1 CARTON
    1 170 g in 1 TUBE
    2 NDC:10237-645-40 1 in 1 CARTON
    2 113.4 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 10/26/2010
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    Name Address ID/FEI Business Operations
    Church & Dwight Co., Inc. 043690812 manufacture
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