Active Ingredient
Undecylenic Acid 10% W/W
Osimoon Fungal Nail Treatment Kit Liquid
FDA Label NDC 85150-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Zanming Trading Co., Ltd. for the product Osimoon Fungal Nail Treatment Kit (NDC 85150-008). 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 active ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Use
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.
Do Not Use
• If you are pregnant or breastfeeding
• your skin is injured or cracked.
• you are under 18 years of age.
• irritation or discomfort occurs.
• you are using other medicines on your nails.
When Using
• 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.
Stop Use
if irritation or symptoms worsen or last for more than 4 weeks.
Ask Doctor
if irritation or symptoms worsen or last for more than 4 weeks.
Keep Oot Of Reach Of Children
If swallowed, get medical help or contact a poison control center right away.
Directions
• Clean the affected area with soap, soak the nail in warm water to soften it.
• Then let it dry, apply a thin layer of the antifungal solution included in the kit 2-3 times a day.
• Apply the fungus nail patch once a night. Firmly secure the patch to the sides of the toes or fingers, folding the remaining adhesive part to fully cover the toes/fingertips.
• Keep the patch in this position for 6-8 hours, preferably overnight, and recommended for 3-6 months.
Other Information
Store at room temperature. Reseal pouch after each use.
Inactive Ingredients
Mineral oil, Apricot Kernel Oil, Tea Tree Oil,Tocopherol, Peppermint Oil, Camphor Oil, Jojoba Oil, Bergamot Oil, Lavender Oil, Hydrogel, Elastic fabric, Adhesive, Release paper
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