NDC 55754-122 Zohar Toothpaste Cool Mint

  1. Labeler Index
  2. Broom Lane Enterprises
  3. NDC: 55754-122 Zohar Toothpaste Cool Mint

NDC Product Code 55754-122

NDC CODE: 55754-122

Proprietary Name: Zohar Toothpaste Cool Mint 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.

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 product is used as anticavity

NDC Code Structure

NDC 55754-122-01

Package Description: 1 TUBE in 1 CARTON > 113.4 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

Zohar Toothpaste Cool Mint with NDC 55754-122 is product labeled by Broom Lane Enterprises. 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 a single concept unique identifier (RXCUI) is 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.
  • CALCIUM CARBONATE (UNII: H0G9379FGK)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • CARVONE, (+/-)- (UNII: 75GK9XIA8I)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • METHYLPARABEN (UNII: A2I8C7HI9T)

Product Labeler Information

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

Labeler Name: Broom Lane Enterprises
Labeler Code: 55754
Start Marketing Date: 02-28-2011 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: 12-31-2017 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.

Zohar Toothpaste Cool Mint Product Label Images

Zohar Toothpaste Cool Mint 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 Ingredients

Sodium monofluorphosphate 1.15% (1500 ppm/ 0.15% w/v fluoride ion)

Purpose

Anticavity

Uses

Aids in the prevention of dental cavities

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children under 6 years of age.If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away.

Directions

  • Do not swallowsupervise children as necessary until capable of using without supervision.adults and children 6 years of age and older Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.children 6 to 12 years instruct in good brushing and rinsing habits(to minimise swallowing)children under 6 years do not use unless directed by dentist or doctor

Inactive Ingredient

Calcium Carbonate, Water, Glycerine, Hydrated Silica, Sodium Lauryl Sulphate, Silica, Cellulose gum, Flavour, Carvone, Sodium Saccharin, Methylparaben, Limonene

Questions?

Call 718 256 9100you may also report serious side effects to this phone number

* Please review the disclaimer below.