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Acclean

Henry Schein Inc.

Drug Facts




FULL PRESCRIBING INFORMATION

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)

Uses

Indications:  Helps prevent dental caries and hypersensitivity

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: 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.

Enter section text here PRECAUTIONS: Federal (USA) Law

prohibits dispensing without prescription. Store at controlled

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

Acclean

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 5 mg

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 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
1997-01-01


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