potassium nitrate and sodium fluoride dentifrice

FDA Drug Profile — Seavue Dental Desensitizer

Drug Details

Generic Name
potassium nitrate and sodium fluoride dentifrice
Brand Names
Seavue Dental Desensitizer
Application Number
M022
Sponsor
Xiling (Zhenjiang) Medical Technology Co., Ltd.
NDC Codes
1
Dosage Forms
GEL, DENTIFRICE
Routes
DENTAL
Active Ingredients
POTASSIUM NITRATE, SODIUM FLUORIDE

Indications and Usage

Adults and children 12 years and older: Apply the product using one of the following methods: Apply evenly on a mouthguard, wear for 15–30 minutes, then remove and rinse. Or apply directly to sensitive teeth using a cotton swab or soft brush. Rub gently, leave for 2–3 minutes, rinse and spit out. Use once or twice daily as needed. Children under 12 years: ask a dentist.

Warnings

Do not use in children under 12 years of age unless recommended by a dentist or physician Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care. Keep out of reach of children. If more than used for treatment is accidentally swallowed, get medical help or contact a Poison Control Center right away. Patients with gingival ulcers, stomatitis, or oral mucosal ulcers should use with caution.