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).

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.

Section 55106-9

UNDECYLENIC ACID 25%


Structured Label Content

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,

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).

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.

Section 55106-9 (55106-9)

UNDECYLENIC ACID 25%


Advanced Ingredient Data


Raw Label Data

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