455ad304-86bc-0abe-e063-6294a90a5b43

SPL v2
SPL
SPL Set ID 455ad304-86bc-0abe-e063-6294a90a5b43
Route
topical
Published
Effective Date 2025-12-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
undecylenic acid (25 g)
Inactive Ingredients
resorcinol water hydracrylic acid euphorbia hirta whole pseudolarix amabilis bark glycerin

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-12-08

Description

UNDECYLENIC ACID 25%


Medication Information

Warnings and Precautions

Warnings

For external use only.

Do not use on children under 2 years of age unless directedby a doctor.

When using this product, avoid contact with eyes.Stop use and ask a doctor if irritation occurs, there is noimprovement within 4 weeks (for athlete's foot andringworm).

Active Ingredient

UNDECYLENIC ACID 25%

Indications and Usage

This product is not effective for thetreatment of ringworm of the scalp or nails. For athlete's foot:pay special attention to spaces between the toes, wearwell-fitting, ventilated shoes, and change shoes and socks atleast once daily. To prevent athlete's foot, apply once ortwice daily(morning and/or night). Apply to skin around thenail and cuticle.

Dosage and Administration

For athlete's foot and ringworm: use daily for 4 weeks, Cleanthe affected area and dry thoroughly. Apply a thin layer ofthe product over affected area twice daily (morning andnight) or as directed by a doctor. Supervise children in theuse of this product,

Description

UNDECYLENIC ACID 25%

Section 50565-1

Keep out of reach of children. lf swallowed, get medical helpor contact a Poison Control Center right away.

Section 51727-6

water, euphorbia hirta whole, glycerin,hydracrylic acid,pseudolarix amabilis bark, resorcinol,

Section 51945-4

Section 55105-1

Cures most Athlete's Foot (Tinea Pedis) and Ringworm(Tinea Corporis). Relieves itching, scaling, cracking, burning,redness, sorenes, and irritation and discomfort.Helpsprevent most athlete's foot (dermatophytosis) with daily use.


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only.

Do not use on children under 2 years of age unless directedby a doctor.

When using this product, avoid contact with eyes.Stop use and ask a doctor if irritation occurs, there is noimprovement within 4 weeks (for athlete's foot andringworm).

Active Ingredient (55106-9)

UNDECYLENIC ACID 25%

Indications and Usage (34067-9)

This product is not effective for thetreatment of ringworm of the scalp or nails. For athlete's foot:pay special attention to spaces between the toes, wearwell-fitting, ventilated shoes, and change shoes and socks atleast once daily. To prevent athlete's foot, apply once ortwice daily(morning and/or night). Apply to skin around thenail and cuticle.

Dosage and Administration (34068-7)

For athlete's foot and ringworm: use daily for 4 weeks, Cleanthe affected area and dry thoroughly. Apply a thin layer ofthe product over affected area twice daily (morning andnight) or as directed by a doctor. Supervise children in theuse of this product,

Section 50565-1 (50565-1)

Keep out of reach of children. lf swallowed, get medical helpor contact a Poison Control Center right away.

Section 51727-6 (51727-6)

water, euphorbia hirta whole, glycerin,hydracrylic acid,pseudolarix amabilis bark, resorcinol,

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Cures most Athlete's Foot (Tinea Pedis) and Ringworm(Tinea Corporis). Relieves itching, scaling, cracking, burning,redness, sorenes, and irritation and discomfort.Helpsprevent most athlete's foot (dermatophytosis) with daily use.


Advanced Ingredient Data


Raw Label Data

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