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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 Mar 1, 2024.

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 and Usage for Acclean Plus

Helps prevent dental caries and hypersensitivity.

Acclean Plus Dosage and Administration

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.

Warnings

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

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
ACCLEAN PLUS
sodium flouride gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0404-6918
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION11 mg in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
Carboxymethylcellulose (UNII: 05JZI7B19X)
Sodium Benzoate (UNII: OJ245FE5EU)
Titanium Dioxide (UNII: 15FIX9V2JP)
Sucralose (UNII: 96K6UQ3ZD4)
Casein (UNII: 48268V50D5)
Sodium Phosphate, Monobasic (UNII: 3980JIH2SW)
Tribasic Calcium Phosphate (UNII: 91D9GV0Z28)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Sodium Phosphate, Dibasic (UNII: GR686LBA74)
Product Characteristics
Color Score
ShapeSize
FlavorMINTImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0404-6918-0140 g in 1 TUBE; Type 0: Not a Combination Product04/15/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/15/2014
ACCLEAN PLUS
sodium flouride gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0404-6919
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION11 mg in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
Carboxymethylcellulose (UNII: 05JZI7B19X)
Sodium Benzoate (UNII: OJ245FE5EU)
Titanium Dioxide (UNII: 15FIX9V2JP)
Sucralose (UNII: 96K6UQ3ZD4)
Casein (UNII: 48268V50D5)
Sodium Phosphate, Monobasic (UNII: 3980JIH2SW)
Tribasic Calcium Phosphate (UNII: 91D9GV0Z28)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Sodium Phosphate, Dibasic (UNII: GR686LBA74)
Product Characteristics
Color Score
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0404-6919-0140 g in 1 TUBE; Type 0: Not a Combination Product04/15/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/15/2014
Labeler - Henry Schein, Inc. (012430880)
Registrant - Henry Schein, Inc. (012430880)
Establishment
NameAddressID/FEIBusiness Operations
Medical Products Laboratories, Inc.002290302manufacture(0404-6918, 0404-6919)