NDC 51460-1113 Amerfresh

  1. Labeler Index
  2. Amercare Products, Inc.
  3. NDC: 51460-1113 Amerfresh

NDC Product Code 51460-1113

NDC CODE: 51460-1113

Proprietary Name: Amerfresh 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 toothpaste

Product Characteristics

Color(s):
PINK (C48328)

NDC Code Structure

NDC 51460-1113-1

Package Description: 57 g in 1 PACKET

NDC 51460-1113-2

Package Description: 446 g in 1 BOX

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

NDC Product Information

Amerfresh with NDC 51460-1113 is product labeled by Amercare Products, Inc.. 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)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
  • PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)

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: 12-20-2011 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.

Amerfresh Product Label Images

Amerfresh 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

Other

Drug Facts

Exclusive Distributor: AMERCARE Products Inc., Seattle., WA 98165-2226.

Active Ingredient

Sodium monofluorophosphate 0.76% (0.1 w/v fluoride ion)

Purpose

Anticavity toothpaste

Use

Aids in the prevention of dental cavities

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center immediately.

Directions For Use

  • Wet toothbrush and dip into powder until brush is fully coveredbrush teeth and gum line for at least 30 seconds, rinse and spit out thoroughlyDo not swallowsupervise children as necessary until capable of using without supervisionInstruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing).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 a doctor.Children under 6 years of age: Do not use unless directed by a doctor or dentist

Inactive Ingredients

Calcium carbonate, sodium carboxymethyl cellulose, sodium saccharin, sodium lauryl sulfate, flavour, silica, sodium methyl paraben, sodium propyl paraben, CI 16255 Q.S.

* Please review the disclaimer below.