SPL v2
SPL
SPL Set ID 3b8b5547-f8d1-9e48-e063-6294a90af429
Route
TOPICAL
Published
Effective Date 2025-08-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Ethylparaben Avocado Oil Cnidium Monnieri Fruit Water Peppermint Oil Dimethicone Melaleuca Alternifolia (tea Tree) Leaf Oil Propylene Glycol Sophora Flavescens Root Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-04

Description

Miconazole Nitrate 2% Antifungal


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

DIRECTIONS

"Clean the affected area and dry thoroughly.

*Apply a thin layer of the product over affected area twicedaily (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 spacesbetween the toes; wear wellfitting, 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.

Dosage and Administration

"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.

Description

Miconazole Nitrate 2% Antifungal

Section 50565-1

Keep out of reach of children.lf swallowed, getmedical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctorif ,lrritation occurs.

"There is no improvement within 4 weeks for athlete'sfoot and ringworm, or within 2 weeks for jock itch.

Section 50567-7

WARNINGS

For external use only.

Section 50570-1

Do not use on children under 2 years of age unlessdirected by a doctor.

Section 51727-6

Water, Peppermint Oil, Glycerin, Propylene Glycol,

Ethylparaben, Dimethicone, Avocado Oil, Cnidium monnieri

Fruit Extract, Melaleuca alternifolia (Tea Tree) Leaf Oil,

Sophora flavescens Root Extract

Section 51945-4

Section 55105-1

Cures most athlete's foot (tinea pedis),

ringworm(tinea corporis) and jock itch (tinea cruris),

Relieves itching, burning and scaling

Section 55106-9

Miconazole Nitrate 2% Antifungal

Section 60561-8

OTHER INFORMATION

Store between 20° to 30°C (68° to 86°F)


Structured Label Content

Indications and Usage (34067-9)

DIRECTIONS

"Clean the affected area and dry thoroughly.

*Apply a thin layer of the product over affected area twicedaily (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 spacesbetween the toes; wear wellfitting, 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.

Dosage and Administration (34068-7)

"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.

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children.lf swallowed, getmedical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctorif ,lrritation occurs.

"There is no improvement within 4 weeks for athlete'sfoot and ringworm, or within 2 weeks for jock itch.

Section 50567-7 (50567-7)

WARNINGS

For external use only.

Section 50570-1 (50570-1)

Do not use on children under 2 years of age unlessdirected by a doctor.

Section 51727-6 (51727-6)

Water, Peppermint Oil, Glycerin, Propylene Glycol,

Ethylparaben, Dimethicone, Avocado Oil, Cnidium monnieri

Fruit Extract, Melaleuca alternifolia (Tea Tree) Leaf Oil,

Sophora flavescens Root Extract

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Cures most athlete's foot (tinea pedis),

ringworm(tinea corporis) and jock itch (tinea cruris),

Relieves itching, burning and scaling

Section 55106-9 (55106-9)

Miconazole Nitrate 2% Antifungal

Section 60561-8 (60561-8)

OTHER INFORMATION

Store between 20° to 30°C (68° to 86°F)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)