Denta 5000 Plus Sensitive
Denta 5000 Plus Sensitive is an FDA drug label for the active ingredient SODIUM FLUORIDE AND POTASSIUM NITRATE manufactured by Rising Pharma Holdings, Inc. administered by DENTAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231109.
- Generic name
- SODIUM FLUORIDE AND POTASSIUM NITRATE
- Manufacturer
- Rising Pharma Holdings, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- DENTAL
- Dosage form
- N/A
- NDC
- 16571-823
- Application
- N/A
- Label effective
- 20231109
Indications & Usage
INDICATIONS AND 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
DOSAGE AND 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.
Contraindications
CONTRAINDICATIONS: Do not use in pediatric patients under age 12 years unless recommended by a dentist or physician.
Warnings
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.
Adverse Reactions
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.