NDC 0404-6918 Acclean Plus

  1. Labeler Index
  2. Henry Schein, Inc.
  3. NDC: 0404-6918 Acclean Plus

NDC Product Code 0404-6918

NDC CODE: 0404-6918

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.

Product Characteristics

Flavor(s):
MINT (C73404)

NDC Code Structure

  • 0404 - Henry Schein, Inc.

NDC 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.

NDC Product Information

Acclean Plus with NDC 0404-6918 is a product labeled by Henry Schein, Inc.. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 392038.

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)

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 - INACTIVATED, the listing data was inactivated by the FDA. 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".

* 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.