Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Undecylenic acid 25%
OTC - PURPOSE SECTION
Antifungal
3ffbccdb-f914-4130-e063-6394a90a9712
- Set ID
- 3ffbccdb-f914-4130-e063-6394a90a9712
- Manufacturer
- Medhome Pharma Inc
- Effective date
- 2025-09-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:15:07
Key Label Information
Uses
INDICATIONS & USAGE SECTION
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.
Warnings
WARNINGS SECTION
For external use only.
OTC - DO NOT USE SECTION
on children under 2 years of age unless directed by a doctor.
Directions And Dosage
DOSAGE & ADMINISTRATION SECTION
30ml/1OZ
Other Label Information
INACTIVE INGREDIENT SECTION
water, euphorbia hirta whole, glycerin, hydracrylic acid, pseudolarix amabilis bark, resorcinol.
Products
- FUNGAL NAIL RENEWAL
- undecylenic acid 25% fungal nail renewal
NDC Codes
Ingredients
| Name | UNII | Kind |
|---|---|---|
| PSEUDOLARIX AMABILIS BARK | 49G13A93VE | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| HYDRACRYLIC ACID | C4ZF6XLD2X | IACT |
| WATER | 059QF0KO0R | IACT |
| EUPHORBIA HIRTA WHOLE | L13YF113GN | IACT |
| UNDECYLENIC ACID | K3D86KJ24N | ACTIB |
| RESORCINOL | YUL4LO94HK | IACT |
Complete SPL Sections
OTC - ACTIVE INGREDIENT SECTION
Undecylenic acid 25%
OTC - PURPOSE SECTION
Antifungal
USE IN SPECIFIC POPULATIONS SECTION
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 SECTION
For external use only.
OTC - DO NOT USE SECTION
on children under 2 years of age unless directed by a doctor.
OTC - WHEN USING SECTION
avoid contact with eyes.
OTC - STOP USE SECTION
irritation occurs, there is no improvement within 4 weeks (for athlete's foot and ringworm).
OTC - ASK DOCTOR SECTION
irritation occurs, there is no improvement within 4 weeks (for athlete's foot and ringworm).
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
If swallowed, get medical help or contact a Poison Control Center right away.
INDICATIONS & USAGE SECTION
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 SECTION
Store at room temperature 15-30℃ (59-86℉)
INACTIVE INGREDIENT SECTION
water, euphorbia hirta whole, glycerin, hydracrylic acid, pseudolarix amabilis bark, resorcinol.
DOSAGE & ADMINISTRATION SECTION
30ml/1OZ
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
- XML object
- dailymed/3ffbccdb-f914-4130-e063-6394a90a9712/3ffbccdb-f915-4130-e063-6394a90a9712.xml
- XML SHA-256
- f59c092a23f95f4d1d88cf2856022aa45f8a5378d7ad19f5290f9dd907e11c28
- XML bytes
- 16903
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 1.jpg | 2025-10-01 |
| otc | 3ffbccdb-f915-4130-e063-6394a90a9712.xml | 2025-10-01 |