Mipaste One Perio Paste, Dentifrice
FDA Label NDC 61596-300
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gc America Inc. for the product Mipaste One Perio (NDC 61596-300). 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 accessories, otc - active ingredient, inactive ingredient, warnings, dosage & administration, indications & usage, otc - keep out of reach of children, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
Stannous fluoride
0.454% w/w
(0.13% w/v fluoride ion)
Inactive Ingredient
Inactive ingredients
Water, Glycerol, Silicon dioxide,
RECALDENT® (CPP-ACP) Casein
Phosphopeptide-Amorphous
Calcium Phosphate, Sorbitol,
CMC-Na, Propylene glycol,
Sodium lauryl sulfate, Sodium
citrate, Flavoring, Titanium dioxide,
Xylitol, Sodium saccharin, Ethyl
p-hydroxybenzoate, Propyl
p-hydroxybenzoate,
Butyl p-hydroxybenzoate
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.
Dosage & Administration
For adults and children 12
years of age or older, apply a
small, pea-size amount of MI Paste
ONE Perio 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.
Indications & 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
Otc - Keep Out Of Reach Of Children
• Keep out of reach of children
Otc - Purpose
Purposes
Anti-gingivitis
Anti-cavity
Anti-sensitivity
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