MIPaste One Perio

Manufacturer
GC America Inc.
Effective date
2025-12-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:27:26

Label at a glance#

ProductMIPaste One Perio
Active ingredientSTANNOUS FLUORIDE
Label structure9 sections

Label contents#

Full prescribing information#

ACCESSORIES

AccessoriesAccessories

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Stannous fluoride
0.454% w/w
(0.13% w/v fluoride ion)

INACTIVE INGREDIENT SECTION

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 SECTION

• 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 SECTION

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 SECTION

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 SECTION

• Keep out of reach of children

OTC - PURPOSE SECTION

Purposes
Anti-gingivitis
Anti-cavity
Anti-sensitivity

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN4
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD4
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY4
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY4
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61596-300-10MIPaste One Perio10 in 1 BOXPASTE, DENTIFRICE104
61596-300-40MIPaste One Perio42 g in 1 TUBEPASTE, DENTIFRICE424
61596-300-41MIPaste One Perio1 in 1 BOTTLE, UNIT-DOSEPASTE, DENTIFRICE14

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61596-30061596-300-40, 61596-300-41, 61596-300-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MIPaste One PerioMIPASTE ONE PERIOGC America Inc.d656b72d-48f8-4425-e053-2995a90ab1f22025-12-19WarningsExact identifier
ndc (package): 61596-300-10
ndc (package): 61596-300-41
ndc (package): 61596-300-40
ndc (product): 61596-300
ndc11 (package): 61596030040
ndc11 (package): 61596030010
ndc11 (package): 61596030041
spl id: 4651cb98-dcfe-a45b-e063-6294a90ad8b2
spl set id: d656b72d-48f8-4425-e053-2995a90ab1f2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.