Label: ACCLEAN - sodium flouride gel, dentifrice
- NDC Code(s): 0404-8016-02
- Packager: Henry Schein Inc.
- 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.
Updated July 27, 2013
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- INACTIVE INGREDIENT
Other Ingredients - Purified water, glycerin, Xylitol and other sweeteners, Contains F D and C Blue No. 1Close
- ACTIVE INGREDIENT
Active Ingredient: Sodium Fluoride 1.1%
(0.5% Fluoride Ion)Close
- INDICATIONS & USAGE
Indications: Helps prevent dental caries and hypersensitivityClose
- 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.Close
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.Close
Enter section text here PRECAUTIONS: Federal (USA) Law
prohibits dispensing without prescription. Store at controlled
room temperature 68 - 77 F (20 - 25 C).Close
- INGREDIENTS AND APPEARANCE
sodium flouride gel, dentifrice
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0404-8016 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 5 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) XYLITOL (UNII: VCQ006KQ1E) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 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)