Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 3.4 FL OZ (100 mL) in plastic bottles. Mint: NDC 0126-0022-92 STORAGE Store at Controlled Room Temperature, 68-77°F (20-25°C); PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label PS0032573 NDC 0126-0022-92 Colgate ® PreviDent ® 5000 ppm Rx Only ENAMEL PROTECT 1.1% Sodium Fluoride 5% Potassium Nitrate PRESCRIPTION STRENGTH TOOTHPASTE For SENSITIVE TEETH mint 3.4 FL OZ (100 mL) PROFESSIONAL PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label
- HOW SUPPLIED 3.4 FL OZ (100 mL) in plastic bottles. Mint: NDC 0126-0022-92 STORAGE Store at Controlled Room Temperature, 68-77°F (20-25°C)
- PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label PS0032573 NDC 0126-0022-92 Colgate ® PreviDent ® 5000 ppm Rx Only ENAMEL PROTECT 1.1% Sodium Fluoride 5% Potassium Nitrate PRESCRIPTION STRENGTH TOOTHPASTE For SENSITIVE TEETH mint 3.4 FL OZ (100 mL) PROFESSIONAL PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label
Overview
Self-topical neutral fluoride toothpaste containing 1.1% (w/w) sodium fluoride and 5% potassium nitrate. Active Ingredients Sodium fluoride 1.1% (w/w), Potassium nitrate 5% Inactive Ingredients water, hydrated silica, sorbitol, PEG-12, carrageenan, sodium lauryl sulfate, flavor, poloxamer 407, titanium dioxide, cocamidopropyl betaine, sodium saccharin, sodium hydroxide, xanthan gum.
Indications & Usage
A dental caries preventive and sensitive teeth toothpaste; for twice daily self-applied topical use, followed by rinsing. Helps reduce the painful sensitivity of the teeth to cold, heat, acids, sweets or contact in adult patients and children 12 years of age and older. 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 Enamel Protect brand of 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste should be used twice 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 children 12 years of age and older: Apply at least a 1 inch strip of PreviDent ® 5000 Enamel Protect onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute, expectorate, and rinse mouth thoroughly. Use twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: Consult a dentist or physician.
Warnings & Precautions
WARNINGS Not for systemic treatment - DO NOT SWALLOW. Keep out of reach of infants and children. Children under 12 years of age, consult a dentist or physician. Note: Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.
Contraindications
Do not use in pediatric patients under age 12 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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