Amerfresh Fluoride
FDA Label NDC 51460-3030

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 Fluoride (NDC 51460-3030). 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 active ingredient, purpose, use, keep out of reach of children under 6 yrs. of age, directions, inactive ingredients, package labeling:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Sodium Fluoride 0.22% (0.1% w/v fluoride ion)

Purpose

Anticavity toothpaste

Use

aids prevention of dental cavities

Keep Out Of Reach Of Children Under 6 Yrs. Of Age

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 2 yrs. and older:  Brush teeth thoroughly after meals or at least twice a day or as directed by a dentist.
  • Do not swallow
  • To 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

sorbitol, water, hydrated silica, sodium lauryl sulfate, sodium carboxymethyl cellulose, flavor, sodium saccharine, sodium methyl paraben, sodium propyl paraben.

Package Labeling:

Label (Label)

Label (Label)

Drugfacts (Drugfacts)

Drugfacts (Drugfacts)

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