Inactive Ingredients
Purified Water, Glycerin, Carboxymethyl Cellulose, Xylitol, Sodium Benzoate, Titanium Dioxide, Sucralose, Casein, Sodium Phosphate Monobasic, Calcium Hydroxyapetite, Silica, Sodium Phosphate Dibasic, Flavor.
Acclean Plus
FDA Label NDC 0404-6918
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Henry Schein, Inc. for the product Acclean Plus (NDC 0404-6918). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding inactive ingredients, active ingredient, indications, directions, warning, precautions, package label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
