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#

ProductFoamgle Foam Mouthwash Super Mint
Active ingredientALLANTOIN
Label structure9 sections

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.

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

Carton ImageCarton Image

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50555-210-01Foamgle Foam Mouthwash Super Mint50 mL in 1 BOTTLELIQUID501
50555-210-02Foamgle Foam Mouthwash Super Mint1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50555-210FOAMGLE FOAM MOUTHWASH SUPER MINT (ALLANTOIN) LIQUID [KMPHARMACEUTICAL CO.,LTD]1Current NDC, 2 package rows20250516_352342bf-e2dd-3a2c-e063-6294a90a200e.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50555-21050555-210-01, 50555-210-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
Foamgle Foam Mouthwash Super MintALLANTOINKMPHARMACEUTICAL CO.,LTD352342bf-e2dd-3a2c-e063-6294a90a200e2025-05-14WarningsExact identifier
ndc (package): 50555-210-02
ndc (package): 50555-210-01
ndc (product): 50555-210
ndc11 (package): 50555021002
ndc11 (package): 50555021001
spl id: 352342bf-e2de-3a2c-e063-6294a90a200e
spl set id: 352342bf-e2dd-3a2c-e063-6294a90a200e

Reported adverse events (FAERS/openFDA)#

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