NDC 51460-3001 Amerfresh Fluoride

NDC Product Code 51460-3001

NDC 51460-3001-1

Package Description: 7.1 g in 1 PACKAGE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Amerfresh Fluoride with NDC 51460-3001 is a product labeled by Amercare Products, Inc.. The generic name of Amerfresh Fluoride is . The product's dosage form is and is administered via form.

Labeler Name: Amercare Products, 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.

  • CALCIUM CARBONATE (UNII: H0G9379FGK)
  • ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
  • CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
  • SORBITOL (UNII: 506T60A25R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)

Product Labeler Information

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

Labeler Name: Amercare Products, Inc.
Labeler Code: 51460
Start Marketing Date: 09-12-2016 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: 12-31-2019 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.

Amerfresh Fluoride Product Label Images

Amerfresh 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

Sodium Monofluorophosphate 0.76%

Purpose

Anticavity toothpaste

Use

Aids in the prevention of dental cavities

Warnings

If more than used for brushing is accidently swallowed, get medical help or contact a poison control center

Otc - Keep Out Of Reach Of Children

Keep out of reach of children under 6 yrs. of age

Directions

  • Adults and children 2 yrs. and older: Brush teeth throughtly after meals or at least twice a day or as directed by a dentist. Do not swallowTo minimize swallowing, use a pea-sized amount in children under 6 years old. Supervise children's brushing until good habits are established. Children under 2 yrs.: ask a dentist before use.

Inactive Ingredients

SODIUM MONOFLUOROPHOSPHATE, CALCIUM CARBONATE, ANHYDROUS DIBASIC CALCIUM PHOSPHATE, CARBOXYMETHYLCELLULOSE, GLYCERIN, ALUMINUM HYDROXIDE, HYDRATED SILICA, POTASSIUM SORBATE, SODIUM LAURYL SULFATE, SORBITAN MONOOLEATE, SORBITOL, TITANIUM DIOXIDE, WATER, XANTHAN GUM.

* Please review the disclaimer below.