FDA records indicate that there are no current recalls for this drug.
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Neutral Sodium Fluoride 0.2% Recall
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Questions & Answers
Side Effects & Adverse Reactions
Keep out of reach of infants and children. Pediatric patients under age 12 should be supervised in the use of this product. Patients under age 6 require special supervision to prevent repeated swallowing of rinse since they frequently swallow significant amounts while rinsing. Prolonged daily ingestion may result in dental fluorosis in patients under age 6, especially if water fluoridation exceeds 0.6 ppm. Read directions carefully before using.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
A dental caries preventative for weekly self-applied topical use. Weekly rinsing with a neutral 0.2% sodium fluoride solution protects against dental caries in pediatric patients. Neutral Sodium Fluoride 0.2% Dental Rinse provides a ready- to-use preparation for convenient administration and favorable compliance. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)
History
There is currently no drug history available for this drug.
Other Information
Neutral Sodium Fluoride 0.2% Dental Rinse is a mint-flavored, neutral, aqueous solution containing 6% alcohol.
Active ingredient: Sodium Fluoride 0.2% (w/v). Contains: FD and C Blue #1.
Inactive ingredients: Purified water, Glycerin, Alcohol 6% (v/v), Xylitol, Sodium Benzoate, Flavor, Magna Sweet, FD and C Blue #1.
Sources
Neutral Sodium Fluoride 0.2% Manufacturers
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Cypress Pharmaceutical, Inc.
Neutral Sodium Fluoride 0.2% | Cypress Pharmaceutical, Inc.
For caries- Adults and pediatric patients over age 6 years, 2 teaspoonfuls (10mL) once a week, preferably at bedtime after thoroughly brushing teeth, rinse vigorously around and between teeth for one minute, then expectorate. DO NOT SWALLOW. For maximum benefit, do not eat, drink, or rinse mouth for at least 30 minutes afterwards.
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