MIPASTE ONE PERIO paste, dentifrice

MIPaste One Perio by

Drug Labeling and Warnings

MIPaste One Perio by is a Otc medication manufactured, distributed, or labeled by GC America Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACCESSORIES

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

PURPOSE

Purposes
Anti-gingivitis
Anti-cavity
Anti-sensitivity

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MIPASTE ONE PERIO 
mipaste one perio paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61596-300
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.454 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CALCIUM PHOSPHATE, UNSPECIFIED FORM (UNII: 97Z1WI3NDX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
XYLITOL (UNII: VCQ006KQ1E)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61596-300-10	10 in 1 BOX	02/01/2022
1	NDC: 61596-300-41	1 in 1 BOTTLE, UNIT-DOSE
1	NDC: 61596-300-40	42 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	02/01/2022

Labeler - GC America Inc. (005473608)

Establishment
Name	Address	ID/FEI	Business Operations
GC America Inc.		005473608	manufacture(61596-300)