SODIUM FLOURIDE

Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients. Active Ingredient Sodium fluoride 1.1% (w/w). Inactive Ingredients Dicalcium Phosphate, FD&C Blue No. 1, Flavor, Glycerin, Hydrated Silica, Purified Water, Sodium Benzoate, Sodium Lauryl Sulfate, Sorbitol, Spearmint Flavor, Titanium Dioxide, Xanthan Gum, Xylitol

A dental caries preventive; for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 Sodium Fluoride 1.1% in a squeeze-tube is easily applied onto a toothbrush. This prescription dental cream should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used whether or not drinking water is fluoridated, since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)

Follow these instructions unless otherwise instructed by your dental professional: 1. Adults and pediatric patients 6 years of age or older, apply a thin ribbon of Sodium Fluoride 1.1% toothpaste to a toothbrush. Brush thoroughly once daily for two minutes, preferably at bedtime. 2. After use, adults expectorate. For best results, do not eat, drink, or rinse for 30 minutes. Pediatric patients, age 6-16, expectorate after use and rinse mouth thoroughly.

Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.

Allergic reactions and other idiosyncrasies have been rarely reported. You should call your doctor, or dental professional for medical advise about serious adverse events. To report a serious adverse event or obtain product information, contact AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 (Toll Free).

STORAGE Store at controlled room temperature 20° - 25°C (68°-77°F). KEEP THIS PRODUCT OUT OF REACH OF CHILDREN Rx Only