Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
Sheffield Pharmaceuticals LLC
DENTAL
PRESCRIPTION DRUG
A dental caries preventive, for weekly self-applied topical use. Weekly rinsing with a neutral 0.2% sodium fluoride solution protects against dental caries in adults and pediatric patients. Wentworth Sodium Fluoride 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.)
Plastic bottle with child-resistant closure containing 16 fl. oz. (473 mL) (NDC 11527-735-16). Store at Controlled Room Temperature, 68-77°F (20-25°C).
unapproved drug other
WENTWORTH ALCOHOL FREE- SODIUM FLUORIDE MOUTHWASH SHEFFIELD PHARMACEUTICALS LLC _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._ ---------- WENTWORTH SODIUM FLUORIDE RINSE _0.2% NEUTRAL SODIUM FLUORIDE_ RX ONLY DESCRIPTION Wentworth Sodium Fluoride Rinse 0.2% of neutral sodium fluoride is a mint-flavored, neutral, aqueous solution. ACTIVE INGREDIENT Sodium Fluoride 0.2% (w/v) INACTIVE INGREDIENTS benzoic acid, flavor, glycerin, poloxamer 338, propylene glycol, sodium benzoate, water, FD&C Blue No. 1 CLINICAL PHARMACOLOGY Topical application of sodium fluoride increases tooth resistance to acid dissolution, promotes remineralization, and inhibits the cariogenic microbial process. INDICATIONS AND USAGE A dental caries preventive, for weekly self-applied topical use. Weekly rinsing with a neutral 0.2% sodium fluoride solution protects against dental caries in adults and pediatric patients. Wentworth Sodium Fluoride 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.) CONTRAINDIACTIONS Do not use in patients with dysphagia. Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician. WARNINGS 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 the water fluoridation exceeds 0.6 ppm. Read directions carefully before using. DO NOT USE IF PRINTED NECK BAND IS BROKEN OR MISSING PRECAUTIONS GENERAL Not for systemic treatment. DO NOT SWALLOW. CARCINOGENES Прочитать полный документ