Amerfresh Fluoride
FDA Label NDC 51460-3002

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 51460-3002). 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, warnings, otc - keep out of reach of children, directions, inactive ingredients, amerfresh fluoride gel toothpaste, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick 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 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

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.

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