Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL - 100 mL Container Label Rising Pharma Holdings, Inc. NDC 16571-823-10 Denta 5000 Plus Sensitive 1.1% Sodium Fluoride, 5% Potassium Nitrate Prescription Strength Toothpaste For Sensitive Teeth Mild Mint 3.4 fl. OZ. (100 mL) Rx only dentaplussen-cont-label dentaplussen-carton-label
- PRINCIPAL DISPLAY PANEL - 100 mL Container Label Rising Pharma Holdings, Inc. NDC 16571-823-10 Denta 5000 Plus Sensitive 1.1% Sodium Fluoride, 5% Potassium Nitrate Prescription Strength Toothpaste For Sensitive Teeth Mild Mint 3.4 fl. OZ. (100 mL) Rx only dentaplussen-cont-label dentaplussen-carton-label
Overview
Self-topical neutral fluoride toothpaste containing 1.1% (w/w) sodium fluoride and 5% potassium nitrate.
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 Denta 5000 Plus Sensitive 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a squeeze tube 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 or older: Apply at least a 1 inch strip of Denta 5000 Plus Sensitive 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. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Storage & Handling
STORAGE: Store at Controlled Room Temperature, 68-77°F (20-25°C).
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