FDA Label for Acclean
View Indications, Usage & Precautions
Acclean Product Label
The following document was submitted to the FDA by the labeler of this product Henry Schein Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Inactive Ingredient
Other Ingredients - Purified water, glycerin, Xylitol and other sweeteners, Contains F D and C Blue No. 1
Otc - 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).
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