Foamgle Foam Mouthwash Super Mint
- Manufacturer
- KMPHARMACEUTICAL CO.,LTD | KMPHARMACEUTICAL Co.,Ltd.
- Effective date
- 2025-05-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:01:03
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient(s)
Allantoin 0.05%
OTC - PURPOSE SECTION
Purpose
Oral Tissue protectant, alleviation of oral irritation
INDICATIONS & USAGE SECTION
Use(s)
■ Aids in the prevention of dental cavities.
■ Helps remove plaque that leads to gingivitis, an early form of gum disease.
■ Helps protect the mouth against everyday irritants
■ Freshens breath while protecting oral tissues
■ Helps soothe and protect irritated gums and mouth
WARNINGS SECTION
Warnings
■ For oral use only; do not swallow.
■ Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
■ Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
■ Stop use and ask a dentist if • Gingivitis, bleeding, or redness persists for more than 2 weeks. • You have painful of swollen gums, pus from the gum line, loose teeth, or increasing spacing between teeth. These may be signs or symptoms of periodontitis, a serious from of gum disease.
■ If pregnant or breast-feeding, ask a health professional before use.
DOSAGE & ADMINISTRATION SECTION
Directions
■ Dispense foam directly into mouth • Swish thoroughly for 30 seconds to 1 minute, and then spit out. Do not swallow the rinse • Use 2–3 times daily or as directed by a dentist or doctor.
OTHER SAFETY INFORMATION
Other Information
■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light
■ Store at 15°–30°C (59°–86°F)
■ Do not freeze.
OTC - QUESTIONS SECTION
Questions
INACTIVE INGREDIENT SECTION
Inactive ingredients
Water, Glycerin, Xylitol, Steviol glucoside, Sodium Lauryl Sulfate, Sodium Bicarbonate, Methylparaben, Polyoxyl 40 Hydrogenated Caster Oil, Flavor, Menthol, Glycyrrhiza Uralensis (Licorice) Extract, Punica Granatum Fruit Extract, Rosmarinus Officinalis (Rosemary) Extract, Chamomilla Recutita (Matricaria) Extract, Propolis Extract, Camellia Sinensis (Green Tea) Leaf Extract
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fb7ab793-2c12-4079-b100-a64f73bef25a | Product name | 4 | 20240712 |
| b0cbf770-6cc3-4aa4-9158-755110c2b9f7 | Product name | 2 | 20230717 |
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50555-210-01 | Foamgle Foam Mouthwash Super Mint | 50 mL in 1 BOTTLE | LIQUID | 50 | 1 | |
| 50555-210-02 | Foamgle Foam Mouthwash Super Mint | 1 in 1 CARTON | LIQUID | 1 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Foamgle Foam Mouthwash Super Mint
- Allantoin
- PEG-40 HYDROGENATED CASTOR OIL
- SODIUM BICARBONATE
- XYLITOL
- METHYLPARABEN
- GLYCERIN
- SODIUM LAURYL SULFATE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50555-210 | 50555-210-01, 50555-210-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PEG-40 HYDROGENATED CASTOR OIL | 7YC686GQ8F | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| XYLITOL | VCQ006KQ1E | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| ALLANTOIN | 344S277G0Z | ACTIB |
| WATER | 059QF0KO0R | IACT |
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 |
|---|---|---|---|---|---|---|
| Foamgle Foam Mouthwash Super Mint | ALLANTOIN | KMPHARMACEUTICAL CO.,LTD | 352342bf-e2dd-3a2c-e063-6294a90a200e | 2025-05-14 | Warnings | 50555-210-02 50555-210-01 50555-210 50555021002 50555021001 352342bf-e2de-3a2c-e063-6294a90a200e 352342bf-e2dd-3a2c-e063-6294a90a200e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
