Drug name: Acclean Plus Prescribing Information

Description:

Acclean Plus Prescribing Information

Package insert / product label
Generic name: sodium fluoride
Dosage form: gel, dentifrice
Drug class: Mouth and throat products

Medically reviewed by Drugs.com. Last updated on Oct 24, 2022.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.

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)

On This Page
  • Indications and Usage
  • Dosage and Administration
  • Warnings
  • Precautions

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.

Related/similar drugs

Biotene, Prevident, fluoride, Prevident 5000 Plus, Denta 5000 Plus

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 LABEL 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
1 NDC:0404-6918-01 40 g in 1 TUBE
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 LABEL 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
1 NDC:0404-6919-01 40 g in 1 TUBE
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, 0404-6919)
Henry Schein, Inc.

More about Acclean Plus (fluoride topical)

  • Side effects
  • Dosage information
  • During pregnancy
  • Drug class: mouth and throat products

Professional resources

  • Prescribing Information

Other brands

Prevident 5000 Plus, Dentagel, Prevident 5000 Dry Mouth, PreviDent 5000 Booster, ... +32 more

Related treatment guides

  • Prevention of Dental Caries

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