Otc - Active Ingredient
Undecylenic acid 25%
Fungal Nail Renewal Liquid
FDA Label NDC 84007-130
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medhome Pharma Inc for the product Fungal Nail Renewal (NDC 84007-130). 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 otc - active ingredient, otc - purpose, use in specific populations, warnings, otc - do not use, otc - when using, otc - stop use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antifungal
Use In Specific Populations
Use
Cures most Athlete's Foot (Tinea Pedis)
and Ringworm (Tinea Corporis). Relieves
itching, scaling, cracking, burning,
redness, sorenes, and irritation and
discomfort. Helps prevent most athlete's
foot (dermatophytosis) with daily use.
Warnings
For external use only.
Otc - Do Not Use
on children under 2 years
of age unless directed by a doctor.
Otc - When Using
avoid contact with eyes.
Otc - Stop Use
irritation occurs, there is no improvement within 4 weeks (for athlete's foot and ringworm).
Otc - Ask Doctor
irritation occurs, there is no improvement
within 4 weeks (for athlete's foot and
ringworm).
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
For athlete's foot and ringworm: use daily for 4 weeks.
Clean theaffected area and dry thoroughly.
Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.
Supervise children in the use of this product.
This product is not effective for the treatment of ringworm of the scalp or nails.
For athlete's foot: pay special attention to spaces between the toes, wear well-fitting,
ventilated shoes, and change shoes and socks at least once daily.
To prevent athlete's foot, apply once or twice daily (morning and/or night).
Apply to skin around the nail and cuticle.
Information For Patients
Store at room temperature 15-30℃ (59-86℉)
Inactive Ingredient
water, euphorbia hirta whole, glycerin, hydracrylic acid, pseudolarix amabilis bark, resorcinol.
Dosage & Administration
30ml/1OZ
Package Label.Principal Display Panel
1 (1)
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