Label: ACCLEAN  - sodium fluoride gel, dentifrice 

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

Drug Label Information

Updated 07/13

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

  • INACTIVE INGREDIENT

    Other Ingredients - Purified water, glycerin, Xylitol and other sweeteners, Contains F D and C Blue No. 1

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  • ACTIVE INGREDIENT

    Active Ingredient: Sodium Fluoride 1.1%

    (0.5% Fluoride Ion)

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  • INDICATIONS & USAGE

    Indications:  Helps prevent dental caries and hypersensitivity

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  • DOSAGE & ADMINISTRATION

    Directions: Adults and children six years of age and older should brush with

    Acclean Home Care Gel once at bedtime. Apply 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, eat, or drink for at least 30 minutes

    after use. Children six years of age and older: expectorate and rinse thoroughly.

    If recommended by your dentist professional, this product can be used in place

    of your regular toothpaste.

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  • WARNINGS

    WARNINGS: 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 INFANTS AND CHILDREN.

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  • PRECAUTIONS

    Enter section text here PRECAUTIONS: Federal (USA) Law

    prohibits dispensing without prescription. Store at controlled

    room temperature 68 - 77 F (20 - 25 C).

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  • INGREDIENTS AND APPEARANCE
    ACCLEAN  
    sodium flouride gel, dentifrice
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0404-8016
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    GLYCERIN  
    XYLITOL  
    FD&C BLUE NO. 1  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0404-8016-02 56 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 01/01/1997
    Labeler - Henry Schein Inc. (012430880)
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