Acclean

ACCLEAN — sodium fluoride gel, dentifrice
Henry Schein Inc.

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.

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

Active Ingredient: Sodium Fluoride 1.1%

(0.5% Fluoride Ion)

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).

copy of label
(click image for full-size original)

ACCLEAN
sodium flouride gel, dentifrice
Product Information
Product Type HUMAN PRESCRIPTION DRUG 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 Multilevel Packaging
1 NDC:0404-8016-02 56 g in 1 TUBE None
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)

Revised: 07/2013 Henry Schein Inc.

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