PREVIDENT 5000 PLUS FRUITASTIC
(+1 other brands)
Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Spearmint Fruitastic™ 1.8 oz. (51 g) net wt. plastic tubes. NDC 0126-0287-66 NDC 0126-0286-66 Twin Pack (two 1.8 oz. (51 g) net wt. tubes) NDC 0126-0287-33 STORAGE Store at controlled room temperature, 68-77°F (20-25°C).; PRINCIPAL DISPLAY PANEL - 51 g Tube Carton - 0287 NDC 0126-0287-66 Colgate ® PreviDent ® 5000 Plus Rx Only 1.1% Sodium Fluoride PRESCRIPTION STRENGTH TOOTHPASTE PROFESSIONAL spearmint 1.8 OZ (51 g) PRINCIPAL DISPLAY PANEL - 51 g Tube Carton - 0287; PRINCIPAL DISPLAY PANEL - 51 g Tube Carton - 0286 NDC 0126-0286-66 Colgate ® PreviDent ® 5000 Plus Rx Only 1.1% Sodium Fluoride PRESCRIPTION STRENGTH TOOTHPASTE PROFESSIONAL fruitastic 1.8 OZ (51 g) PRINCIPAL DISPLAY PANEL - 51 g Tube Carton - 0286
- HOW SUPPLIED Spearmint Fruitastic™ 1.8 oz. (51 g) net wt. plastic tubes. NDC 0126-0287-66 NDC 0126-0286-66 Twin Pack (two 1.8 oz. (51 g) net wt. tubes) NDC 0126-0287-33 STORAGE Store at controlled room temperature, 68-77°F (20-25°C).
- PRINCIPAL DISPLAY PANEL - 51 g Tube Carton - 0287 NDC 0126-0287-66 Colgate ® PreviDent ® 5000 Plus Rx Only 1.1% Sodium Fluoride PRESCRIPTION STRENGTH TOOTHPASTE PROFESSIONAL spearmint 1.8 OZ (51 g) PRINCIPAL DISPLAY PANEL - 51 g Tube Carton - 0287
- PRINCIPAL DISPLAY PANEL - 51 g Tube Carton - 0286 NDC 0126-0286-66 Colgate ® PreviDent ® 5000 Plus Rx Only 1.1% Sodium Fluoride PRESCRIPTION STRENGTH TOOTHPASTE PROFESSIONAL fruitastic 1.8 OZ (51 g) PRINCIPAL DISPLAY PANEL - 51 g Tube Carton - 0286
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 Ingredient Sodium fluoride 1.1% (w/w). Inactive Ingredients water, sorbitol, hydrated silica, PEG-12, tetrapotassium pyrophosphate, sodium lauryl sulfate, flavor (Spearmint flavor only), xanthan gum, flavor (Fruitastic™ flavor only), sodium benzoate, sodium saccharin, titanium dioxide (Fruitastic™ flavor only), FD&C blue no. 1 (Spearmint flavor only), D&C red no. 33 (Fruitastic™ flavor only).
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 PreviDent® 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 & 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 PreviDent® 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 years, 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 dental cream which could cause dental fluorosis. Read directions carefully before using. Keep out of reach of infants and children.
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
STORAGE Store at controlled room temperature, 68-77°F (20-25°C).
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