ACCLEAN- sodium flouride gel, dentifrice

Acclean by

Drug Labeling and Warnings

Acclean by is a Prescription medication manufactured, distributed, or labeled by Henry Schein Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ACCLEAN  
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)