Otc - Active Ingredient
Sodium fluoride
0.24% w/w
Potassium nitrate
5% (w/w)
Mipaste One Paste, Dentifrice
FDA Label NDC 61596-400
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gc America Inc. for the product Mipaste One (NDC 61596-400). 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 otc - active ingredient, indications & usage, warnings, dosage & administration, inactive ingredient, otc - keep out of reach of children, otc - purpose, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
- aids in prevention of dental cavities
- builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
Warnings
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 or hydroxybenzoates allergy. In case of allergic reaction, stop use, rinse mouth with water and seek medical advice.
Dosage & Administration
For adults and children 12 years of age or older, apply a small, pea-size amount of MI Paste One to your toothbrush. For best results, brush for 2 minutes, expectorate and do not rinse; do not eat or drink for 30 minutes after brushing. Use twice daily. Replace cap after use. For children under 12 years of age, consult a dentist or physician.
Inactive Ingredient
Inactive ingredient Pure water, Glycerol, RECALDENT (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
Otc - Keep Out Of Reach Of Children
Warning Keep out of reach of children.
Otc - Purpose
Anti-cavity
Anti-sensitivity
* Please review the disclaimer below.
