Drug Catalog - Product Detail
SODIUM FLUORIDE CRM. (DENTA 5000 PLUS) CRM 0.011 1.8OZ
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 64980-0305-50 | RISING PHARMACEUTICALS | 51 | 1.1% | CREAM |
PACKAGE FILES
Generic Name
SODIUM FLUORIDE
Substance Name
SODIUM FLUORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
Description
DESCRIPTION: Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventative in adults and pediatric patients.
How Supplied
HOW SUPPLIED: Spearment 1.8 oz. (51g) net wt. tube (2) 1.8 oz. (51g) net wt. tubes (twin pack) NDC# 64980-305-50 NDC# 64980-306-50 STORAGE: Store at Controlled Room Temperature, 20-25°C (68-77°F)
Indications & Usage
INDICATIONS AND 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 Denta 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 in areas where drinking water is fluoridated, since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)
Dosage and Administration
DOSAGE AND ADMINISTRATION: Follow these instructions unless otherwise instructed by your dental professional: Adults and pediatric patients 6 years of age or older, apply a thin ribbon of Denta 5000 Plus to a toothbrush. Brush thoroughly once daily for two minutes, preferably at bedtime. After use, adults expectorate. For best results, do not eat, drink, or rinse for 30 minutes. Pediatric patients, ages 6-16, expectorate after use and rinse mouth thoroughly.