NDC 0404-6918 Acclean Plus

Product Information

What is NDC 0404-6918?

The NDC code 0404-6918 is assigned by the FDA to the product Acclean Plus which is product labeled by Henry Schein, Inc.. The product's dosage form is and is administered via form. The product is distributed in a single package with assigned NDC code 0404-6918-01 40 g in 1 tube . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code0404-6918
Proprietary Name 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.		Acclean Plus
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Henry Schein, Inc.
Labeler Code0404
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		04-15-2014
Listing Expiration Date 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.		12-31-2019
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		I
NDC Code Structure

What are the uses for Acclean Plus?


Product Characteristics

Flavor(s)MINT (C73404)

Product Packages

NDC Code 0404-6918-01

Package Description: 40 g in 1 TUBE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

Acclean Plus Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Acclean Plus Inactive Ingredients UNII Codes

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.

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Patient Education

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

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



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 68° - 77° F (20°C - 25°C).

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



* Please review the disclaimer below.