Myco®

Myco®
SPL v6
SPL
SPL Set ID 550358d7-69e8-4ea3-bcf9-d647c457287d
Route
TOPICAL
Published
Effective Date 2025-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (250 mg)
Inactive Ingredients
Benzyl Acetate Benzyl Alcohol Cetylpyridinium Chloride Chloroxylenol Eucalyptol Acetic Acid Isopropyl Alcohol Propionic Acid Propylene Glycol Sodium Propionate Triacetin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-01-14

Description

Undecylenic acid 25%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Undecylenic acid 25%

Uses

• Proven clinically effective in the treatment of most athlete’s foot, jock itch, and ringworm

• For effective relief of itching, scaling, cracking, burning and discomfort.

Section 42229-5

Manufactured in the USA for Kramer Novis

San Juan, PR 00917

KramerNovis

Pharmaceuticals within reach of patients

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only.

Flammable: Keep away from fire and flame.

Do not use on children under 2 years of age, unless directed by a doctor.

When using this product

• avoid contact with the eyes.

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)

Packaging

Directions

• wash and dry the affected area and dry thoroughly

• apply a thin layer of the product over the affected area twice daily (morning and night), or as directed by a doctor

• supervise children in the use of this product

• 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

• for athlete’s foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks

• if condition persists longer, consult a doctor

• this product is not effective on the scalp or nails

Drug Facts

Active Ingredient

Undecylenic acid 25%

Other Information

• Store between 15° – 30°C (59° – 86°F).

• Tamper Evident Feature: Do not use if safety seal around cap is torn, broken or missing.

• Retain carton for full prescribing information.

Inactive Ingredients

Benzyl acetate, benzyl alcohol, cetylpyridinium chloride, chloroxylenol, eucalyptol, glacial acetic acid, Isopropyl alcohol, propionic acid, propylene glycol, sodium propionate and triacetin.

Questions Or Comments?

call weekdays from 8 am to 4 pm AST at 1.787.767.2072


Structured Label Content

Uses

• Proven clinically effective in the treatment of most athlete’s foot, jock itch, and ringworm

• For effective relief of itching, scaling, cracking, burning and discomfort.

Section 42229-5 (42229-5)

Manufactured in the USA for Kramer Novis

San Juan, PR 00917

KramerNovis

Pharmaceuticals within reach of patients

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Antifungal

Warnings

For external use only.

Flammable: Keep away from fire and flame.

Do not use on children under 2 years of age, unless directed by a doctor.

When using this product

• avoid contact with the eyes.

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)

Packaging

Directions

• wash and dry the affected area and dry thoroughly

• apply a thin layer of the product over the affected area twice daily (morning and night), or as directed by a doctor

• supervise children in the use of this product

• 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

• for athlete’s foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks

• if condition persists longer, consult a doctor

• this product is not effective on the scalp or nails

Drug Facts

Active Ingredient (Active ingredient)

Undecylenic acid 25%

Other Information (Other information)

• Store between 15° – 30°C (59° – 86°F).

• Tamper Evident Feature: Do not use if safety seal around cap is torn, broken or missing.

• Retain carton for full prescribing information.

Inactive Ingredients (Inactive ingredients)

Benzyl acetate, benzyl alcohol, cetylpyridinium chloride, chloroxylenol, eucalyptol, glacial acetic acid, Isopropyl alcohol, propionic acid, propylene glycol, sodium propionate and triacetin.

Questions Or Comments? (Questions or comments?)

call weekdays from 8 am to 4 pm AST at 1.787.767.2072


Advanced Ingredient Data


Raw Label Data

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