Acclean plus

Manufacturer
Henry Schein
Effective date
2021-01-25
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:55:14

Label at a glance#

ProductAcclean plus
Active ingredientSODIUM FLUORIDE
Label structure7 sections

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 ...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT:

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 1.1%  (0.5% Fluoride Ion)

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

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:

DOSAGE & ADMINISTRATION SECTION

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:

INDICATIONS & USAGE SECTION

Helps prevent dental caries and hypersensitivity.

WARNING:

WARNINGS SECTION

 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:

PRECAUTIONS SECTION

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

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0404-01180404-0118-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
049e609b-4ef5-c302-e063-6394a90ac2ce63b0de92-d0fb-4909-b3ae-145316ff4b512023-09-05WarningsExact identifier
spl set id: 63b0de92-d0fb-4909-b3ae-145316ff4b51

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.