Active Ingredient
Sodium fluoride
0.24% w/w Anti-cavity
Potassium nitrate
5% (w/w)* Anti-sensitivity
*Maximum FDA sensitivity active ingredient
The following Structured Product Label (SPL) was submitted to the FDA by Gc America Inc. for the product Mipaste (NDC 61596-437). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, use, warning, directions, inactive ingredient, question or comments, otc - purpose, tube box, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Sodium fluoride
0.24% w/w Anti-cavity
Potassium nitrate
5% (w/w)* Anti-sensitivity
*Maximum FDA sensitivity active ingredient
-aids in the prevention of dental cavities
-builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
Warning If the sensitivity persists after 4 weeks of use, consult a dentist or physician. Keep out of reach of children. 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 and/or hydroxybenzoates allergy. In case of allergic reaction, stop use, rinse mouth with water and seek medical advice.
Keep out of reach of children.
For adults and children 12 years of age or older, apply a small, pea-sized amount of MI Paste One to your toothbrush. For best results, brush for 2 minutes, expectorate and do not rinse; use twice a day. Replace cap after use. For children under 12 years of age, consult a dentist or physician.
Pure water, Glycerol, RECALDENT TM (CPP-ACP) Casein Phosphopeptide-Amorphous Calcium Phosphate, Sorbitol, CMC-Na, Propylene glycol, Silicon dioxide, Titanium dioxide, Xylitol, Phosphoric acid, flavoring, Methyl salicylate, Sodium saccharin, Ethyl p-hydroxybenzoate, Propyl p-hydroxybenzoate, Butyl p-hydroxybenzoate, Sodium-N-lauroyl sarcosinate
1-708-323-7063 www.gcamerica.com
Anti-cavity toothpaste with bio-available calcium.
Anti-cavity
Rebuilds enamel
Helps against sensitivity
Sodium Fluoride 0.24% w/w (1,100ppmF)
Potassium Nitrate 5% w/w/
* Please review the disclaimer below.