ACCLEAN PLUS- sodium flouride gel, dentifrice

Acclean plus by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT:

Sodium Fluoride 1.1% (0.5% Fluoride Ion)

INACTIVE INGREDIENTS:

Purified Water, Glycerin, Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Sucralose, Xylitol, Sodium Benzoate, Titanium Dioxide, 

Sylodent 756 (Silica), Casein, Microcrystalline Calcium Hydroxyapatite, Spearmint Oil, Peppermint Oil, Carboxymethyl Cellulose, Phosphoric Acid, 
Sodium Hydroxide 

DIRECTIONS:

Adults and children six years of age and older should brush with Acclean Plus Home Care Gel once at bedtime ( or as directed by physician or dentist). Apply a 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, drink or eat for at least 30 minutes after use.

CHILDREN SIX YEARS OF AGE AND OLDER: Expectorate and rinse thoroughly.

If recommended by your dental professional, this product can be used in place of your regular toothpaste. Read all instructions and prescribing information before using this product.

INDICATIONS:

Helps prevent dental caries and hypersensitivity.

WARNING:

 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 CHILDREN AND INFANTS. This product should not be used by individuals with milk allergies.

PRECAUTIONS:

Federal (USA) Law prohibits dispensing without prescription. Store at controlled room temperature 68 - 77 F (20° C - 25° C). 

Principal display panel

INGREDIENTS AND APPEARANCE

ACCLEAN PLUS 
sodium flouride gel, dentifrice

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0404-0118
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)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CASEIN (UNII: 48268V50D5)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
SPEARMINT OIL (UNII: C3M81465G5)
PEPPERMINT OIL (UNII: AV092KU4JH)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0404-0118-04	113.4 g in 1 TUBE; Type 0: Not a Combination Product	09/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/30/2019

Labeler - Henry Schein (012430880)

Registrant - Henry Schein (012430880)

Establishment
Name	Address	ID/FEI	Business Operations
Medical Products Laboratories, Inc.		002290302	manufacture(0404-0118)