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#
Label contents#
Full prescribing information#
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
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 416784 | stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste | PSN | 4 |
| 416784 | stannous fluoride 0.00454 MG/MG Toothpaste | SCD | 4 |
| 416784 | stannous fluoride 0.454 % (fluoride ion 0.14 % ) Toothpaste | SY | 4 |
| 416784 | stannous fluoride 0.454 % (fluoride ion 0.15 % ) Toothpaste | SY | 4 |
| 416784 | stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste | SY | 4 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61596-300-10 | MIPaste One Perio | 10 in 1 BOX | PASTE, DENTIFRICE | 10 | 4 | |
| 61596-300-40 | MIPaste One Perio | 42 g in 1 TUBE | PASTE, DENTIFRICE | 42 | 4 | |
| 61596-300-41 | MIPaste One Perio | 1 in 1 BOTTLE, UNIT-DOSE | PASTE, DENTIFRICE | 1 | 4 |
Products#
Every source-derived product name is available through these pages.
- MIPaste One Perio
- WATER
- CALCIUM PHOSPHATE, UNSPECIFIED FORM
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
- GLYCERIN
- SILICON DIOXIDE
- SACCHARIN SODIUM
- ETHYLPARABEN
- PROPYLENE GLYCOL
- SORBITOL
- SODIUM LAURYL SULFATE
- XYLITOL
- PROPYLPARABEN
- BUTYLPARABEN
- SODIUM CITRATE, UNSPECIFIED FORM
- TITANIUM DIOXIDE
- STANNOUS FLUORIDE
- FLUORIDE ION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61596-300 | 61596-300-40, 61596-300-41, 61596-300-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| MIPaste One Perio | MIPASTE ONE PERIO | GC America Inc. | d656b72d-48f8-4425-e053-2995a90ab1f2 | 2025-12-19 | Warnings | 61596-300-10 61596-300-41 61596-300-40 61596-300 61596030040 61596030010 61596030041 4651cb98-dcfe-a45b-e063-6294a90ad8b2 d656b72d-48f8-4425-e053-2995a90ab1f2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

