FDA Label for Mipaste One
View Indications, Usage & Precautions
Mipaste One Product Label
The following document was submitted to the FDA by the labeler of this product Gc America Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Sodium fluoride
0.24% w/w Anti-cavity
Potassium nitrate
5% (w/w)* Anti-sensitivity
*Maximum FDA sensitivity active ingredient
Use
-aids in the prevention of dental cavities
-builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
Warning
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.
Directions
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.
Inactive Ingredient
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
Question Or Comments
1-708-323-7063 www.gcamerica.com
Otc - Purpose
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/
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