Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Active ingredient(s) Allantoin 0.05%
OTC - PURPOSE SECTION
Purpose Oral Tissue protectant, alleviation of oral irritation
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
Key Label Information#
Uses
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
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.
Directions And Dosage
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 Label Information
OTC - QUESTIONS SECTION
Questions ■ www.foamgle.com
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
Label Images#
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#
- Foamgle Foam Mouthwash Super Mint
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50555-210 | 50555-210-01, 50555-210-02 |
Ingredients#
| 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 |
Complete SPL Sections#
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 ■ www.foamgle.com
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