NDC 0404-0118 Acclean Plus

Sodium Flouride

NDC Product Code 0404-0118

NDC CODE: 0404-0118

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: Sodium Flouride 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to prevent cavities. It makes teeth stronger and more resistant to decay caused by acid and bacteria. Talk to your dentist or doctor about the benefits and risks of this product. This medication is not recommended for use in infants less than 6 months of age. This medication is not recommended for use in areas where the fluoride content in the water supply is greater than 0.6 parts per million. See Notes section for more information.

NDC Code Structure

NDC 0404-0118-04

Package Description: 113.4 g in 1 TUBE

NDC Product Information

Acclean Plus with NDC 0404-0118 is a a human prescription drug product labeled by Henry Schein. The generic name of Acclean Plus is sodium flouride. The product's dosage form is gel, dentifrice and is administered via oral form.

Labeler Name: Henry Schein

Dosage Form: Gel, Dentifrice - A combination of a dentifrice (formulation intended to clean and/or polish the teeth, and which may contain certain additional agents), and a gel. It is used with a toothbrush for the purpose of cleaning and polishing the teeth.

Product Type: Human Prescription Drug 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.

Acclean Plus Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SODIUM FLUORIDE 5 mg/g

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)
  • SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
  • SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • XYLITOL (UNII: VCQ006KQ1E)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CASEIN (UNII: 48268V50D5)
  • TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
  • SPEARMINT OIL (UNII: C3M81465G5)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
  • PHOSPHORIC ACID (UNII: E4GA8884NN)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

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
Labeler Code: 0404
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 09-30-2019 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: 12-31-2020 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: N 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’.

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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

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).

* Please review the disclaimer below.