Active Ingredient
Undecylenic Acid 25%
Fungal Nail Treatment Liquid
FDA Label NDC 85308-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gaoye Marketing Inc for the product Fungal Nail Treatment (NDC 85308-003). 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
For the effective treatment of nail fungus,discoloration, thickening, splitting,crumbling and brittleness.
Warnings
For external use only.
Do not use● on children under 2 years of age unless directed by a doctor.
Stop use and ask a doctor
●if irritation occurs or if there is no improvement within 4 weeks.
When using this product●Possible
side effects may include mild skin irritation, redness, or itching at the application site. Discontinue use and consult a doctor if severe reactions(e.g., swelling, rash) occur.
Keep out of reach of children.
If swallowed,get medical help or contacta Poison Control Center right away.
Do Not Use
on children under 2 years of age unless directed by a doctor.
When Using
When using this product●Possible
side effects may include mild skin irritation, redness, or itching at the application site. Discontinue use and consult a doctor if severe reactions(e.g., swelling, rash) occur.
Stop Use
Stop use and ask a doctor
●if irritation occurs or if there is no improvement within 4 weeks.
Ask Doctor
Stop use and ask a doctor
●if irritation occurs or if there is no improvement within 4 weeks.
Keep Oot Of Reach Of Children
Keep out of reach of children.
If swallowed,get medical help or contacta Poison Control Center right away.
Directions
1. Apply the product twice a day, in the morning and at night.
2.For initial use, soak the affected nail in warm water to soften it. Gently file thenail to make it thinner and remove dirt, being cautious not to harm the nail bed.For best results file nails every 2-3 days.
3. Hold the bottle at an angle to pour 2-3 drops.Use the brush applicator to applythe solution on the affected areas.
4. For best results, use this product consistenthy for 3-6 months, as fungal nail infections require prolonged treatment. Visible improvements may appear in as little as 7 days, but complete healing takes longer.
Other Information
Preservation method
Store in a cool, shaded place away from direct sunlight. Store at room temperature between15-30°C(59-86°F).
Inactive Ingredients
Aloe Vera Extract, Canola Oil, Clove Bud Oil,Lavender Oil, Jojoba Oil, Manuka Oil, Oregano Oil,Peppermint Oil, Propolis Extract, Sweet Almond Oil.Tea Tree Oil, Tocopheryl Acetate.
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