Amerfresh
FDA Label NDC 51460-1113

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amercare Products, Inc. for the product Amerfresh (NDC 51460-1113). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, otc - keep out of reach of children, directions for use, inactive ingredients, principal display panel - 57 g packet label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick 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 covered
  • brush teeth and gum line for at least 30 seconds, rinse and spit out thoroughly
  • Do not swallow
  • supervise children as necessary until capable of using without supervision
  • Instruct 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.

Principal Display Panel - 57 G Packet Label

AMERFRESH®
FLUORIDE TOOTHPOWDER

NET WT. 2 oz (57g)

Principal Display Panel (57 g Packet Label)

Principal Display Panel (57 g Packet Label)

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