Drugplain

SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint 50 mg/g

potassium nitrate and sodium fluoride · PASTE · Haleon US Holdings LLC

No Recall HistoryCurrently in Shortage
Plain English

SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint is a paste containing potassium nitrate and sodium fluoride at 50 mg/g, taken oral. Manufactured by Haleon US Holdings LLC.

Key Facts

Brand Name
SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint
Generic Name
potassium nitrate and sodium fluoride
NDC Code (Product)
0135-0492
Manufacturer
Haleon US Holdings LLC
Strength
50 mg/g
Dosage Form
PASTE
Route
ORAL
Marketing Status
Application #
M022
Marketing Start
11/29/2018

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

pyrexia170 reports
fatigue159 reports
nausea158 reports
vomiting156 reports
pain154 reports
weight increased154 reports
nasopharyngitis152 reports
type 2 diabetes mellitus145 reports
peripheral swelling144 reports
urticaria143 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses • aids in the prevention of dental cavities. • the combined daily use of a fluoride preventive treatment rinse and a fluoride toothpaste can help reduce the incidence of dental cavities.

Dosage & Administration

Directions • adults and children 6 years of age and older: • use once a day after brushing your teeth with a toothpaste. • pour 10 milliliters into cap (10 mL mark on inside of cap); do not fill above the 10 mL mark. • vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out. • do not swallow the rinse. • do not drink from the bottle. • do not rinse mouth with water. • do not eat or drink for 30 minutes after rinsing. • instruct children under 12 years of age in good rinsing habits (to minimize swallowing). • supervise children as necessary until capable of using without supervision. • children under 6 years of age: Consult a dentist or doctor.

Warnings

Warning Keep Out of Reach of Children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint used for?

SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint contains potassium nitrate and sodium fluoride. It is a paste taken oral. Consult your doctor for specific uses.

Is SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint a controlled substance?

SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint is not classified as a controlled substance by the DEA.

What is the generic name for SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint?

The generic name for SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint is potassium nitrate and sodium fluoride. There are 11 other brand versions of potassium nitrate and sodium fluoride.

What is the NDC code for SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint 50 mg/g?

The NDC (National Drug Code) for SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint 50 mg/g is 0135-0492, listed by Haleon US Holdings LLC.