NDC 0135-0557 Biotene Fresh Mint Original

NDC Product Code 0135-0557

NDC 0135-0557-01

Package Description: 1 TUBE in 1 CARTON > 121.9 g in 1 TUBE

NDC 0135-0557-02

Package Description: 1 TUBE in 1 CARTON > 19.8 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

Biotene Fresh Mint Original with NDC 0135-0557 is product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The product's dosage form is and is administered via form.

RxNorm Crosswalk

What is RxNorm?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) (RxCUI) to each NDC.

The RxNorm Crosswalk for this NDC code indicates multiple concept unique identifiers (RXCUI) are associated with this product:


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)
  • SORBITOL (UNII: 506T60A25R)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code: 0135
Start Marketing Date: 07-15-2013 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: 12-31-2022 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...
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* Please review the disclaimer below.

Biotene Fresh Mint Original 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 (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Keep Out Of Reach Of Children 12 Years Of Age And Under (Fresh Mint And Gentle Mint)

If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away. Do not use if you are allergic to any of the ingredients.

Keep Out Of Reach Of Children 12 Years Of Age And Under. (Pbf)

If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away. If symptoms of a dry mouth persist, consult a healthcare professional. Do not use if you are allergic to any of the ingredients.

Directions

  • Adults and children over 12 years •apply toothpaste onto a soft bristle toothbrush •brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician.Children 12 years and under ask a dentist or physician. Once recommended, to minimize swallowing for children under 6, use a pea-sized amount and supervise brushing until good habits are established.

Other Information

Store below 25°C (77F°)

Inactive Ingredients (Fresh Mint Original)

Water, Sorbitol, Hydrated Silica, Glycerin, PEG-8, Cocamidopropyl Betaine, Xanthan Gum, Flavor, Sodium Saccharin, Sucralose, Titanium Dioxide, Sodium Hydroxide

Inactive Ingredients (Gentle Mint)

Water, Sorbitol, Hydrated Silica, Glycerin, PEG-8, Cocamidopropyl Betaine, Xanthan Gum, Flavor, Sodium Saccharin, Sucralose, Sodium Hydroxide, D&C Yellow #10, FD&C Blue #1

Inactive Ingredients (Pbf)

Water, Sorbitol, Hydrated Silica, Glycerin, PEG-8, Cocamidopropyl Betaine, Xanthan Gum, Flavor, Sodium Saccharin, Sucralose, Sodium Hydroxide, Dextranase, D&C Yellow #10, FD&C Blue #1

* Please review the disclaimer below.