Label: ACCLEAN PLUS- sodium flouride gel, dentifrice

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated November 3, 2018

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  • Inactive Ingredients

    Purified Water, Glycerin, Carboxymethyl Cellulose, Xylitol, Sodium Benzoate, Titanium Dioxide, Sucralose, Casein, Sodium Phosphate Monobasic, Calcium Hydroxyapetite, Silica, Sodium Phosphate Dibasic, Flavor.

  • Active Ingredient

     Sodium Fluoride 1.1%

    (0.5% Fluoride Ion)

  • Indications

    Helps prevent dental caries and hypersensitivity.

  • Directions

    Adults and children six years of age and older should brush with Acclean® Plus Home Care Gel once at bedtime (or as directed by physician or dentist).  Apply a thin bead of gel to toothbrush and brush for at least one minute, making sure all tooth surfaces are covered.  ADULTS:  Expectorate thoroughly.  Do not rinse, drink or eat for at least 30 minutes after use.  CHILDREN SIX YEARS OF AGE AND OLDER:  Expectorate and rinse thoroughly.  If recommended by your dental professional, this product can be used in place of your regular toothpaste.   Read all instructions and prescribing information before using this product.

  • Warning

    DO NOT SWALLOW.  To avoid ingestion, supervision is required while children are using this product.  Swallowing excessive amounts of fluoride could cause dental fluorosis.  KEEP OUT OF REACH OF CHILDREN AND INFANTS.  This product should not be used by individuals with milk allergies.   

  • Precautions

    Federal (U.S.A.) Law prohibits dispensing without prescription.  Store at controlled room temperature 68º - 77º F (20ºC - 25ºC).

    Reorder # 112-6918
    Reorder # 112-6919  

    Distributed by (In US Only) HENRY SCHEIN INC.
    135 DURYEA ROAD
    Melville, NY 11747 USA

  • Package Label

    NDC 0404-6918-01

    HENRY SCHEIN®
    ACCLEAN® PLUS

    HOME CARE GEL

    HENRY SCHEIN SEAL OF EXCELLENCE®

    1.1% NEUTRAL SODIUM FLUORIDE
    Contains MCH-C*
    *(Micronized Calcium Hydroxyapatite & Casein)

    MINT FLAVOR

    Net Wt. 1.4 oz. (40g)

    Rx Only


    label

    NDC 0404-6919-01

    HENRY SCHEIN®
    ACCLEAN® PLUS

    HOME CARE GEL

    HENRY SCHEIN SEAL OF EXCELLENCE®

    1.1% NEUTRAL SODIUM FLUORIDE
    Contains MCH-C*
    *(Micronized Calcium Hydroxyapatite & Casein)

    BUBBLE GUM FLAVOR

    Net Wt. 1.4 oz. (40g)

    Rx Only


    LABEL
  • INGREDIENTS AND APPEARANCE
    ACCLEAN PLUS  
    sodium flouride gel, dentifrice
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0404-6918
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION11 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Carboxymethylcellulose (UNII: 05JZI7B19X)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Casein (UNII: 48268V50D5)  
    Sodium Phosphate, Monobasic (UNII: 3980JIH2SW)  
    Tribasic Calcium Phosphate (UNII: 91D9GV0Z28)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Sodium Phosphate, Dibasic (UNII: GR686LBA74)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0404-6918-0140 g in 1 TUBE; Type 0: Not a Combination Product04/15/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/15/2014
    ACCLEAN PLUS  
    sodium flouride gel, dentifrice
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0404-6919
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION11 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Carboxymethylcellulose (UNII: 05JZI7B19X)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Casein (UNII: 48268V50D5)  
    Sodium Phosphate, Monobasic (UNII: 3980JIH2SW)  
    Tribasic Calcium Phosphate (UNII: 91D9GV0Z28)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Sodium Phosphate, Dibasic (UNII: GR686LBA74)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0404-6919-0140 g in 1 TUBE; Type 0: Not a Combination Product04/15/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/15/2014
    Labeler - Henry Schein, Inc. (012430880)
    Registrant - Henry Schein, Inc. (012430880)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medical Products Laboratories, Inc.002290302manufacture(0404-6918, 0404-6919)
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