Acclean Plus

ACCLEAN PLUS — 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.

labelLABEL

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

label
(click image for full-size original)

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

LABEL
(click image for full-size original)
ACCLEAN PLUS sodium flouride gel, dentifrice
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0404-6918
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 11 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
XYLITOL
Carboxymethylcellulose
Sodium Benzoate
Titanium Dioxide
Sucralose
Casein
Sodium Phosphate, Monobasic
Tribasic Calcium Phosphate
Silicon Dioxide
Sodium Phosphate, Dibasic
Product Characteristics
Color Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0404-6918-01 40 g in 1 TUBE None
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 11 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
XYLITOL
Carboxymethylcellulose
Sodium Benzoate
Titanium Dioxide
Sucralose
Casein
Sodium Phosphate, Monobasic
Tribasic Calcium Phosphate
Silicon Dioxide
Sodium Phosphate, Dibasic
Product Characteristics
Color Score
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0404-6919-01 40 g in 1 TUBE None
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 Operations
Medical Products Laboratories, Inc. 002290302 manufacture (0404-6918), manufacture (0404-6919)

Revised: 11/2018 Henry Schein, Inc.

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