Amerfresh
FDA Label NDC 73398-114

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Suhan Aerosol for the product Amerfresh (NDC 73398-114). 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 ingredients, purpose, uses, warnings, directions, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Sodium fluoride-0.22%

Purpose

Anticavity Toothpaste.

Uses

aids in the prevention of dental cavities

Warnings

  • 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 right away.

Directions

  • 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.
  •  Do not swallow.
  • To minimize the 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

Calcium Carbonate, Water,Sorbitol,Hydrated Silica, Sodium Lauryl Sulphate,Sodium Carboxymethyl cellulose, Flavor, Sodium Saccharin, Sodium methyl paraben, Sodium propyl paraben.

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