NDC 0135-0487 Biotene Fresh Mint Original

NDC Product Code 0135-0487

NDC 0135-0487-01

Package Description: 1 TUBE in 1 CARTON > 127.6 g in 1 TUBE

NDC 0135-0487-02

Package Description: 1 TUBE in 1 CARTON > 21.3 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 0135-0487 is a product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Biotene Fresh Mint Original is . The product's dosage form is and is administered via form.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc

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.

  • SORBITOL (UNII: 506T60A25R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)
  • WATER (UNII: 059QF0KO0R)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • XYLITOL (UNII: VCQ006KQ1E)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)
  • CETETH-20 (UNII: I835H2IHHX)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • LACTOPEROXIDASE BOVINE (UNII: 01UIN5OC49)
  • POTASSIUM THIOCYANATE (UNII: TM7213864A)
  • GLUCOSE OXIDASE (UNII: 0T8392U5N1)
  • LYSOZYME, CHICKEN EGG WHITE (UNII: 1ZML031Y3C)
  • TALACTOFERRIN ALFA (UNII: 7A055A9QRR)
  • CALCIUM LACTATE (UNII: 2URQ2N32W3)

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: 04-18-2011 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: 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.

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(Fresh Mint Original)

Sodium monofluorophosphate (0.14% w/v fluoride ion)

Active Ingredient (Gentle Mint)

Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities.

Keep Out Of Reach Of Children 12 Years And Under.

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.

When Using This Product,

If irritation occurs discontinue use.

Keep Out Of Reach Of Children Under 6 Years Of Age.

If more than used for bushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions (Fresh Mint Original)

  • 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.

Directions (Gentle Mint)

  • •adults and children 2 years of age and older:oapply toothpaste onto a toothbrushobrush teeth thoroughly, preferable after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimizing swallowing. Spit out after brushing.oto minimize swallowing for children under 6 years of age, use a pea-sized amoun and supervise brushing and rinsing until good habits are established. •children under 2 years of age: Consult a dentist or doctor.

Other Information

Store at or below 25ºC (77ºF)

Inactive Ingredients (Fresh Mint Original)

Sorbitol, Glycerin, Calcium Pyrophosphate, Water, Hydrated Silica, Xylitol, Silica, Hydroxyethylcellulose, Isoceteth-20, Cellulose Gum, Flavor, Sodium Benzoate, Lactoperoxidase, Potassium Thiocyanate, glucose Oxidase, Lysozyme, Lactoferrin, Calcium Lactate. Contains milk and egg derivatives.

Inactive Ingredients (Gentle Mint)

Sorbitol, hydrated silica, glycerin, calcium pyrophosphate, water, xylitol, silica, hydroxyethylcellulose, isoceteth-20, cellulose gum, flavor, sodium benzoate, calcium lactate.

* Please review the disclaimer below.