Label: ACCLEAN- sodium flouride gel, dentifrice

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated July 27, 2013

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

View All Sections
  • INACTIVE INGREDIENT

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

  • ACTIVE INGREDIENT

    Active Ingredient: Sodium Fluoride 1.1%

    (0.5% Fluoride Ion)

  • INDICATIONS & USAGE

    Indications:  Helps prevent dental caries and hypersensitivity

  • 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.

  • 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.

  • PRECAUTIONS

    Enter section text here PRECAUTIONS: Federal (USA) Law

    prohibits dispensing without prescription. Store at controlled

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

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    ACCLEAN  
    sodium flouride gel, dentifrice
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0404-8016
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0404-8016-0256 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/1997
    Labeler - Henry Schein Inc. (012430880)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!