3ffbccdb-f914-4130-e063-6394a90a9712

SPL v1
SPL
SPL Set ID 3ffbccdb-f914-4130-e063-6394a90a9712
Route
topical
Published
Effective Date 2025-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-09-30

Description

Undecylenic acid 25%


Medication Information

Warnings and Precautions

For external use only.

Active Ingredient

Undecylenic acid 25%

Indications and 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.

Dosage and Administration

30ml/1OZ

Description

Undecylenic acid 25%

Section 34076-0

Store at room temperature 15-30℃ (59-86℉)

Section 43684-0

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.

Section 50565-1

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

Section 50566-9

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

Section 50567-7

avoid contact with eyes.

Section 50569-3

irritation occurs, there is no improvement

within 4 weeks (for athlete's foot and

ringworm).

Section 50570-1

on children under 2 years

of age unless directed by a doctor.

Section 51727-6

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

Section 51945-4

Section 55105-1

Antifungal


Structured Label Content

Warnings and Precautions (34071-1)

For external use only.

Active Ingredient (55106-9)

Undecylenic acid 25%

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

30ml/1OZ

Section 34076-0 (34076-0)

Store at room temperature 15-30℃ (59-86℉)

Section 43684-0 (43684-0)

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.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

avoid contact with eyes.

Section 50569-3 (50569-3)

irritation occurs, there is no improvement

within 4 weeks (for athlete's foot and

ringworm).

Section 50570-1 (50570-1)

on children under 2 years

of age unless directed by a doctor.

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)

Antifungal


Advanced Ingredient Data


Raw Label Data

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