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, Inc., Medical Products Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Inactive Ingredients

Purified Water, Glycerin, Carboxymethyl Cellulose, Xylitol, Sodium Benzoate, Titanium Dioxide, Sucralose, Casein, Sodium Phosphate Monobasic, Calcium Hydroxyapetite, Silica, Sodium Phosphate Dibasic, Flavor.

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® 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.

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 (U.S.A.) Law prohibits dispensing without prescription.  Store at controlled room temperature 68º - 77º F (20ºC - 25ºC).

Reorder # 112-6918
Reorder # 112-6919  

Distributed by (In US Only) HENRY SCHEIN INC.
135 DURYEA ROAD
Melville, NY 11747 USA

Package Label

NDC: 0404-6918-01

HENRY SCHEIN®
ACCLEAN® PLUS

HOME CARE GEL

HENRY SCHEIN SEAL OF EXCELLENCE®

1.1% NEUTRAL SODIUM FLUORIDE

Contains MCH-C*
*(Micronized Calcium Hydroxyapatite & Casein)

MINT FLAVOR

Net Wt. 1.4 oz. (40g)

Rx Only

NDC: 0404-6919-01

HENRY SCHEIN®
ACCLEAN® PLUS

HOME CARE GEL

HENRY SCHEIN SEAL OF EXCELLENCE®

1.1% NEUTRAL SODIUM FLUORIDE

Contains MCH-C*
*(Micronized Calcium Hydroxyapatite & Casein)

BUBBLE GUM FLAVOR

Net Wt. 1.4 oz. (40g)

Rx Only

INGREDIENTS AND APPEARANCE

ACCLEAN PLUS  
sodium flouride gel, dentifrice

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0404-6918
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	11 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
Carboxymethylcellulose (UNII: 05JZI7B19X)
Sodium Benzoate (UNII: OJ245FE5EU)
Titanium Dioxide (UNII: 15FIX9V2JP)
Sucralose (UNII: 96K6UQ3ZD4)
Casein (UNII: 48268V50D5)
Sodium Phosphate, Monobasic (UNII: 3980JIH2SW)
Tribasic Calcium Phosphate (UNII: 91D9GV0Z28)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Sodium Phosphate, Dibasic (UNII: GR686LBA74)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0404-6918-01	40 g in 1 TUBE; Type 0: Not a Combination Product	04/15/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/15/2014

ACCLEAN PLUS  
sodium flouride gel, dentifrice

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0404-6919
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	11 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
Carboxymethylcellulose (UNII: 05JZI7B19X)
Sodium Benzoate (UNII: OJ245FE5EU)
Titanium Dioxide (UNII: 15FIX9V2JP)
Sucralose (UNII: 96K6UQ3ZD4)
Casein (UNII: 48268V50D5)
Sodium Phosphate, Monobasic (UNII: 3980JIH2SW)
Tribasic Calcium Phosphate (UNII: 91D9GV0Z28)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Sodium Phosphate, Dibasic (UNII: GR686LBA74)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0404-6919-01	40 g in 1 TUBE; Type 0: Not a Combination Product	04/15/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/15/2014

Labeler - Henry Schein, Inc. (012430880)

Registrant - Henry Schein, Inc. (012430880)

Establishment
Name	Address	ID/FEI	Business Operations
Medical Products Laboratories, Inc.		002290302	manufacture(0404-6918, 0404-6919)