Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 1.8 oz. (51 g) net wt. tube Flavor: Spearmint NDC 69367-309-51 You should call your doctor for medical advice about serious adverse events. To report a serious adverse event or obtain product information, contact Westminster Pharmaceuticals, LLC at 1-844-221-7294 or FDA at 1-800-FDA-1088 (Toll Free). Rx Only; PRINCIPAL DISPLAY PANEL - 51 g Tube Carton SPEARMINT NDC 69367-309-51 Rx Only Sodium Fluoride 5000 Plus 1.1% SODIUM FLUORIDE Prescription Dental Cream 5000 ppm Fluoride Plus Mild Cleaning System NET WT. 1.8 OZ. (51 g) Westminster Pharmaceuticals PRINCIPAL DISPLAY PANEL - 51 g Tube Carton
- HOW SUPPLIED 1.8 oz. (51 g) net wt. tube Flavor: Spearmint NDC 69367-309-51 You should call your doctor for medical advice about serious adverse events. To report a serious adverse event or obtain product information, contact Westminster Pharmaceuticals, LLC at 1-844-221-7294 or FDA at 1-800-FDA-1088 (Toll Free). Rx Only
- PRINCIPAL DISPLAY PANEL - 51 g Tube Carton SPEARMINT NDC 69367-309-51 Rx Only Sodium Fluoride 5000 Plus 1.1% SODIUM FLUORIDE Prescription Dental Cream 5000 ppm Fluoride Plus Mild Cleaning System NET WT. 1.8 OZ. (51 g) Westminster Pharmaceuticals PRINCIPAL DISPLAY PANEL - 51 g Tube Carton
Overview
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 INGREDIENTS: Sodium Fluoride USP 1.1% (w/w) INACTIVE INGREDIENTS: FD&C Blue No. 1, glycerin, hydrated silica, purified water, sodium benzoate, sodium lauryl sulfate, sorbitol, spearmint flavor, titanium dioxide, xanthan gum, dicalcium phosphate, xylitol
Indications & Usage
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 SF 5000 Plus brand of 1.1% sodium fluoride 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.)
Dosage & Administration
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 SF 5000 Plus 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.
Warnings & Precautions
WARNINGS Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm, since younger pediatric patients frequently cannot perform the brushing process without significant swallowing. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of the dental cream which could cause dental fluorosis. Read directions carefully before using. If using a mouthpiece application, prolonged exposure (longer than 1 minute) may result in oral irritation, such as burning. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSAGE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Contraindications
Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.
Adverse Reactions
Allergic reactions and other idiosyncrasies have been rarely reported.
Storage & Handling
You should call your doctor for medical advice about serious adverse events. To report a serious adverse event or obtain product information, contact Westminster Pharmaceuticals, LLC at 1-844-221-7294 or FDA at 1-800-FDA-1088 (Toll Free). Rx Only
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