MIPaste One

FDA Drug Profile — MIPaste One

Drug Details

Generic Name
MIPaste One
Brand Names
MIPaste One
Application Number
M021
Sponsor
GC America Inc.
NDC Codes
1
Dosage Forms
PASTE, DENTIFRICE
Routes
DENTAL
Active Ingredients
POTASSIUM NITRATE, SODIUM FLUORIDE

Indications and Usage

Uses • Helps prevent gingivitis • Helps interfere with harmful effects of plaque associated with gingivitis • Aids in the prevention of cavities • Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact

Warnings

• Keep out of reach of children • Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks, or if you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs of periodontitis, a serious form of gum disease. • When using this product for sensitivity, do not use longer than 4 weeks unless recommended by a dentist. • If more than the recommended amount of paste used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not use on patients with a milk protein or hydroxybenzoates allergy. In case of allergic reaction, stop use, rinse mouth with water and seek medical advice.