Otc - Active Ingredient
Active ingredient(s)
Allantoin 0.05%
Foamgle Foam Super Mint Mouthwash
FDA Label NDC 50555-220
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kmpharmaceutical Co.,ltd for the product Foamgle Foam Super Mint (NDC 50555-220). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, dosage & administration, other safety information, otc - questions, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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.
Otc - 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
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