Sodium fluoride and Potassium nitrate

FDA Drug Profile — Denta 5000 Plus Sensitive, BIO SPECTRA ATTITUDE, PreviDent 5000 Sensitive

Sodium fluoride and Potassium nitrate is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand names including Denta 5000 Plus Sensitive, BIO SPECTRA ATTITUDE, PreviDent 5000 Sensitive. Available dosage forms: gel, dentifrice, paste, dentifrice.

Drug Details

Generic Name
Sodium fluoride and Potassium nitrate
Brand Names
Denta 5000 Plus Sensitive, BIO SPECTRA ATTITUDE, PreviDent 5000 Sensitive
Application Number
M022
Sponsor
Rising Pharma Holdings, Inc.
NDC Codes
3
Dosage Forms
GEL, DENTIFRICE, PASTE, DENTIFRICE
Routes
DENTAL
Active Ingredients
SODIUM FLUORIDE, POTASSIUM NITRATE

Indications and Usage

Use Aids in the prevention of dental decay Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact

Warnings

Warnings Do not use if irritation occurs and persists. When using this product do not use longer than 4 weeks 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 by a dentist. Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.