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

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

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.