FDA Label for Foamgle Foam Mouthwash Super Mint
View Indications, Usage & Precautions
Foamgle Foam Mouthwash Super Mint Product Label
The following document was submitted to the FDA by the labeler of this product Kmpharmaceutical Co.,ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient(s)
Allantoin 0.05%
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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