FDA records indicate that there are no current recalls for this drug.
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Neutral Sodium Fluoride Recall
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Questions & Answers
Side Effects & Adverse Reactions
DO NOT SWALLOW. Keep out of reach of infants and children. Pediatric populations under the age of 12 years should be supervised in the use of this product. Patients under the age of 6 years require special supervision to prevent repeated swallowing of the rinse since they may frequently swallow large amounts while rinsing. Prolonged daily ingestion may result in dental fluorosis in patients under the age of 6 years, especially if water fluoridation exceeds 0.6 ppm. Read directions 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
For once weekly use as a dental caries preventative in pediatric patients.
History
There is currently no drug history available for this drug.
Other Information
Neutral Sodium Fluoride 0.2% Dental Rinse is a grape flavored, neutral, aqueous solution containing no alcohol.
ACTIVE INGREDIENT: Sodium Fluoride 0.2% (w/v).
INACTIVE INGREDIENTS: Purified water, Glycerin, Xylitol, Propylene Glycol, Natural Grape Type Flavor, Methylparaben, Sucralose, Propylparaben.
Sources
Neutral Sodium Fluoride Manufacturers
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Sancilio & Company Inc
Neutral Sodium Fluoride | Sancilio & Company Inc
For caries – Adults and pediatric patients over 6 years of age, 2 teaspoonfuls (10 mL) once a week, preferably at bedtime after thoroughly brushing teeth, rinse vigorously around and between the teeth for one minute, then spit out. DO NOT SWALLOW. For maximum benefit, do not eat, drink, or rinse mouth for at least 30 minutes after treatment.
For caries – Adults and pediatric patients over 6 years of age, 2 teaspoonfuls (10 mL) once a week, preferably at bedtime after thoroughly brushing teeth, rinse vigorously around and between the teeth for one minute, then spit out. DO NOT SWALLOW. For maximum benefit, do not eat, drink, or rinse mouth for at least 30 minutes after treatment.
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