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  5. Label Information: Acclean Plus

FDA Label for Acclean Plus

View Indications, Usage & Precautions

Table of Contents

    1. INACTIVE INGREDIENTS
    2. ACTIVE INGREDIENT
    3. INDICATIONS
    4. DIRECTIONS
    5. WARNING
    6. PRECAUTIONS
    7. PACKAGE LABEL

Acclean Plus Product Label

The following document was submitted to the FDA by the labeler of this product Henry Schein, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 68° - 77° F (20°C - 25°C).

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



* Please review the disclaimer below.