potassium nitrate

FDA Drug Profile — SENSODYNE Advanced Whitening, SENSODYNE Advanced Whitening Plus

Drug Details

Generic Name
potassium nitrate
Brand Names
SENSODYNE Advanced Whitening, SENSODYNE Advanced Whitening Plus
Application Number
M022
Sponsor
Haleon US Holdings LLC
NDC Codes
3
Dosage Forms
PASTE, POWDER
Routes
ORAL
Active Ingredients
POTASSIUM NITRATE, SODIUM FLUORIDE

Indications and 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 adults 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 Sodium Fluoride 5000 ppm Enamel Protect brand of 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a 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 in used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)

Warnings

WARNINGS: Not for systemic treatment- DO NOT SWALLOW. Keep out of the 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.