Active Ingredient
Active ingredient: Undecylenic Acid 10%
Osimoon Fungal Nail Renewal Liquid
FDA Label NDC 87408-006
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 Jingliang Cosmetics Co., Ltd. for the product Osimoon Fungal Nail Renewal (NDC 87408-006). 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, ask doctor, do not use, keep oot of reach of children, purpose, stop use, when using, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Ask Doctor
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 18 years of age.
• irritation or discomfort occurs.
• you are using other medicines on your nails.
Keep Oot Of Reach Of Children
If swallowed, get medical help or contact a poison control center right away.
Purpose
Antifungal
Stop Use
Discontinue use if necessary and ask a doctor:
Chest pain, rapid heart rate, fainting, and dizziness may occur.
Sudden, unexplained weight gain.
Your hands or feet swell.
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.
Inactive Ingredients
Mineral oil, Apricot Kernel Oil, Tea Tree Oil,Tocopherol, Peppermint Oil, Camphor Oil, Jojoba Oil, Bergamot Oil, Lavender Oil
Directions
Soak your feet in warm water to soften your toenails or fingernails.
Use the nail file to polish the nails, make them thin visibly, then scrap the dirt on the nails.
Brush liquid on infected nails and allow to absorb and dry.
Apply two more layers of liquid, ensuring liquid is fully absorbed before each new stroke.
For best results, use fungus nail renewal two or three times a day.
Continue to use daily until fungus infection has been completely healed.
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.
Uses
To treat damaged, cracked, or discolored nails.
Package Label.Principal Display Panel
Product Name: OSIMOON FUNGAL NAIL RENEWAL
Net Contents: 2x15ml (0.5 fl.oz.) Bottles
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