FDA Label for Oetmoe Antifungal Solution
View Indications, Usage & Precautions
Oetmoe Antifungal Solution Product Label
The following document was submitted to the FDA by the labeler of this product Shenzhen Earth Surface Trading 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.
Active Ingredients
Undecylenic Acid 25% W/W
Purpose
Antifungal
Uses
Effective in getting rid of fungus and promoting healthier nail growth.
Warnings
• For external use only.
• When using this product avoid contact with eyes. If contact occurs,
rinse thoroughly with water.
• Stop use and ask/ consult a doctor/ physician/ health care
practitioner/ health care provider/ health care professional if irritation
or symptoms worsen or last for more than 4 weeks.
• Keep out of reach of children. If swallowed, call a poison control
centre or get medical help right away、
Stop Use And Ask A Doctor If
if irritation or symptoms worsen
or last for more than 4 weeks.
Do Not Use
• If you are pregnant or breastfeeding
• your skin is injured or cracked.
• you are under 12 years of age.
• irritation or discomfort occurs.
• you are using other medicines on your nails.
When Using This Product
• Do not apply to other parts of the body.
• Avoid making eye contact. In case of accidental eye contact, flush
eyes with copious amounts of cold tap water.
• This product may not work for everyone.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a poison control center right away.
Inactive Ingredients
Water
Directions
Soak the affected nail inwarm water
to soften it. Gently file the nail to
thin it and remove dirt, being cau-
tious not to harm the nail bed.
Application: Apply full layers of
the solution with the brush onto
affected areas on, around, and
under the nails.a light tingle or burn
is normal for the first 10 minutes
until absorbed.
Frequency: Use twice daily
(morningand night). Visible results
may appear in 6 weeks. Continue
regular use to prevent regrowth.
Package Label.Principal Display Panel
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