Acclean Plus

ACCLEAN PLUS- sodium fluoride gel, dentifrice
Henry Schein

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.

ACTIVE INGREDIENT:

Sodium Fluoride 1.1% (0.5% Fluoride Ion)

INACTIVE INGREDIENTS:

Purified Water, Glycerin, Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Sucralose, Xylitol, Sodium Benzoate, Titanium Dioxide,

Sylodent 756 (Silica), Casein, Microcrystalline Calcium Hydroxyapatite, Spearmint Oil, Peppermint Oil, Carboxymethyl Cellulose, Phosphoric Acid,
Sodium Hydroxide

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.

INDICATIONS:

Helps prevent dental caries and hypersensitivity.

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 (USA) Law prohibits dispensing without prescription. Store at controlled room temperature 68 — 77 F (20° C — 25° C).

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ACCLEAN PLUS
sodium flouride gel, dentifrice
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0404-0118
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
SUCRALOSE
XYLITOL
SODIUM BENZOATE
TITANIUM DIOXIDE
SILICON DIOXIDE
CASEIN
TRIBASIC CALCIUM PHOSPHATE
SPEARMINT OIL
PEPPERMINT OIL
CARBOXYMETHYLCELLULOSE
PHOSPHORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0404-0118-04 113.4 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/30/2019
Labeler — Henry Schein (012430880)
Registrant — Henry Schein (012430880)

Revised: 01/2021 Henry Schein

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