Fluorabon Drops

Generic name:sodium fluoride
Dosage form: solution

Medically reviewed by Drugs.com. Last updated on Dec 22, 2021.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

DESCRIPTION:

Perry Fluorabon Drops (0.25 mg Fluoride ion per 0.6 ml) are dye free. Each 0.6 ml contains 0.25 mg of the fluoride ion (F) from 0.55 mg sodium fluoride (NaF). Each 0.6 ml for oral administration contains sodium fluoride equivalent to 0.25 mg of the fluoride ion and the following inactive ingredients:

Purified Water USP, Methylparaben, Propylparaben.

CLINICAL PHARMACOLOGY:

Sodium fluoride acts systemically (before tooth eruption) and topically (post eruption) by increasing tooth resistance to acid dissolution, by promoting remineralization, and by inhibiting the cariogenic microbial process.

INDICATIONS AND USAGE:

For once daily, self-administered, systemic use as a dental caries preventive in pediatric patients. It has been established that ingestion of fluoridated drinking water (1 ppm F) during the period of tooth development results in a significant decrease in the incidence of dental caries. Perry Fluorabon Drops (0.25 mg Fluoride ion per 0.6 ml) were developed to provide systemic fluoride for use as a supplement in pediatric patients from 6 months to 16 years of age living in areas where the drinking water fluoride content does not exceed 0.6 ppm (F).

CONTRAINDICATIONS:

Perry Fluorabon Drops (0.25 mg Fluoride ion per .6 ml), are contraindicated when the fluoride content of drinking water is 0.6 ppm (F) or more and should not be administered to pediatric patients under the age of 6 months. Do not administer fluoride (any strength) to pediatric patients under age 6 months.

WARNINGS:

Prolonged daily ingestion of quantities greater than the recommended amount may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 pm. Read directions carefully before using.