NDC 55312-158 Western Family Sensitive Whitening Fluoride

NDC Product Code 55312-158

NDC CODE: 55312-158

Proprietary Name: Western Family Sensitive Whitening Fluoride 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: 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.

Product Characteristics

Color(s):
WHITE (C48325)

NDC Code Structure

  • 55312 - Western Family Food, Inc.
    • 55312-158 - Western Family Sensitive Whitening Fluoride

NDC 55312-158-09

Package Description: 113 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

Western Family Sensitive Whitening Fluoride with NDC 55312-158 is a product labeled by Western Family Food, Inc.. The generic name of Western Family Sensitive Whitening Fluoride is . The product's dosage form is and is administered via form.

Labeler Name: Western Family Food, Inc.

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)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM PHOSPHATE (UNII: SE337SVY37)
  • SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Labeler Information

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

Labeler Name: Western Family Food, Inc.
Labeler Code: 55312
Start Marketing Date: 05-02-2007 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: 12-31-2017 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.

Western Family Sensitive Whitening Fluoride Product Label Images

Western Family Sensitive Whitening Fluoride 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

Potassium Nitrate 5%..................AntihypersensitivitySodium Fluoride 0.243% (0.15% w/v fluoride ion).......Anticavity Toothpaste

Use

  • Builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contactaids in the prevention of dental cavities

Warnings

When using this product do not use longer than 4 weeks unless recommended by a dentist or doctor.  Stop and ask a dentist if problem persists or worsens.  Sensitive teeth may indicate a serious problem that may require prompt care by a dentist.  Keep out of reach of children.

Directions

Adults and children          Brush teeth for at least one minute, preferably after 12 years and older           each meal, or at least twice a day, or as directed by your dentist.                                            Be sure to brush sensitive areas.Children under                 Consult a dentist or doctor.12 years of ageOther information            Store in a cool, dry place.

Inactive Ingredients

Sorbitol, Silica, Water, Sodium Lauryl Sulphate, Flavor, Cellulose gum, Titanium Dioxide, Sodium Benzoate, Sodium Phosphate, Tetrasodium Pyrophosphate, Sodium Saccharin

* Please review the disclaimer below.