SPL v1
SPL
SPL Set ID 477c971d-829f-5040-e063-6394a90a41e4
Routes
CUTANEOUS EXTRACORPOREAL PERCUTANEOUS
Published
Effective Date 2026-01-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (25 g)
Inactive Ingredients
Jojoba Oil Aloe Vera Leaf Syzygium Aromaticum Fruit Vitamin E Polyethylene Glycol Succinate Tea Tree Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-03

Description

Undecylenic acid 25%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Undecylenic acid 25%

Uses

cures most athlete's foot (tinea pedis)

cures most jock itch (tinea cruris)

cures most ringworm (tinea corporis)

for effective relief of itching,burning,cracking,and discomfort which may accompany these conditions

Label

Warning

For external use only

Directions

wash the affected area and dry thoroughly apply one patch to cover the affected nail surface or surrounding skin press firmly to ensure adhesion replace with a new patch every 8-12 hours (morning and night) continue use for 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch); if condition persists longer, consult a doctor

Active Ingredient

Undecylenic acid 25%

Inactive Ingredients

Tea Tree Oil, Jojoba Oil, Vitamin E, Aloe Vera, Clove Bud

When Using This Product

When using this product

avoid contact with eyes

if irritation occurs,discontinue use and consult a doctor use only as directed

Stop Use and Ask A Doctor

Stop use and ask a doctor if

irritation occurs

there is no improvement within 4 weeks(for athlete's foot and ringworm)

or within 2 weeks(for jock itch)

Keep Out of Reach of Children

keep out of reach of children

If swallowed,get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

cures most athlete's foot (tinea pedis)

cures most jock itch (tinea cruris)

cures most ringworm (tinea corporis)

for effective relief of itching,burning,cracking,and discomfort which may accompany these conditions

Label

Purpose

Antifungal

Warning

For external use only

Directions

wash the affected area and dry thoroughly apply one patch to cover the affected nail surface or surrounding skin press firmly to ensure adhesion replace with a new patch every 8-12 hours (morning and night) continue use for 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch); if condition persists longer, consult a doctor

Active Ingredient (Active ingredient)

Undecylenic acid 25%

Inactive Ingredients (Inactive ingredients)

Tea Tree Oil, Jojoba Oil, Vitamin E, Aloe Vera, Clove Bud

When Using This Product (When using this product)

When using this product

avoid contact with eyes

if irritation occurs,discontinue use and consult a doctor use only as directed

Stop Use and Ask A Doctor (Stop use and ask a doctor)

Stop use and ask a doctor if

irritation occurs

there is no improvement within 4 weeks(for athlete's foot and ringworm)

or within 2 weeks(for jock itch)

Keep Out of Reach of Children (keep out of reach of children)

keep out of reach of children

If swallowed,get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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