FOAMGLE FOAM MOUTHWASH SUPER MINT- allantoin liquid

Foamgle Foam Mouthwash Super Mint by

Drug Labeling and Warnings

Foamgle Foam Mouthwash Super Mint by is a Otc medication manufactured, distributed, or labeled by KMPHARMACEUTICAL CO.,LTD, KMPHARMACEUTICAL Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient(s)

Allantoin 0.05%

PURPOSE

Purpose

Oral Tissue protectant, alleviation of oral irritation

INDICATIONS & USAGE

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

■ 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

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.

QUESTIONS

Questions

■ www.foamgle.com

INACTIVE INGREDIENT

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

KEEP OUT OF REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FOAMGLE FOAM MOUTHWASH SUPER MINT 
allantoin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50555-210
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PEG-40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
XYLITOL (UNII: VCQ006KQ1E)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50555-210-02	1 in 1 CARTON	05/01/2025
1	NDC: 50555-210-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/01/2025

Labeler - KMPHARMACEUTICAL CO.,LTD (689850153)

Establishment
Name	Address	ID/FEI	Business Operations
KMPHARMACEUTICAL Co.,Ltd.		689850153	manufacture(50555-210)