NDC 0404-6919 Acclean Plus
NDC Product Code 0404-6919
Proprietary Name: Acclean Plus What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name: What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
NDC Code Structure
- 0404 - Henry Schein, Inc.
- 0404-6919 - Acclean Plus
NDC 0404-6919-01
Package Description: 40 g in 1 TUBE
NDC Product Information
Acclean Plus with NDC 0404-6919 is a product labeled by Henry Schein, Inc.. The generic name of Acclean Plus is . The product's dosage form is and is administered via form.
Labeler Name: Henry Schein, Inc.
Dosage Form: -
Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Inactive Ingredient(s)
About the Inactive Ingredient(s)The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.
- 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)
- 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 Labeler Information
What is the Labeler Name?Name of Company corresponding to the labeler code segment of the Product NDC.
Labeler Name: Henry Schein, Inc.
Labeler Code: 0404
Start Marketing Date: 04-15-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
Exclude Flag: I What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.
* Please review the disclaimer below.
Information for Patients
Fluoride
Fluoride is pronounced as (floor' ide)
Why is fluoride medication prescribed?
Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usu...
[Read More]
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Acclean Plus Product Label Images
Acclean Plus Product Labeling Information
The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Labeling Index
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
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 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® PLUSHOME CARE GELHENRY SCHEIN SEAL OF EXCELLENCE®1.1% NEUTRAL SODIUM FLUORIDEContains MCH-C**(Micronized Calcium Hydroxyapatite & Casein)MINT FLAVORNet Wt. 1.4 oz. (40g)Rx OnlyNDC 0404-6919-01 HENRY SCHEIN®ACCLEAN® PLUSHOME CARE GELHENRY SCHEIN SEAL OF EXCELLENCE®1.1% NEUTRAL SODIUM FLUORIDEContains MCH-C**(Micronized Calcium Hydroxyapatite & Casein)BUBBLE GUM FLAVORNet Wt. 1.4 oz. (40g)Rx Only
* Please review the disclaimer below.