SPL v2
SPL
SPL Set ID 43cbad59-9899-ab3b-e063-6294a90a9e12
Route
TOPICAL
Published
Effective Date 2025-11-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (20 mg)
Inactive Ingredients
Aloe Barbadensis Leaf Paraffinum Liquidum Dictamnus Dasycarpus Root Bark Tocopherol Sophora Flavescens Root Glycerin Cnidium Monnieri Fruit Borneol Petrolatum Stearic Acid Triethanolamine Stemona Japonica Root Menthol Aqua

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-19

Description

Miconazole Nitrate 2%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Anti-fungal for the effective treatment of Athlete's Foot, Jock Itch, Ringworm, Eczema, Tinea Versicolor, and fungal folliculitis.

Dosage and Administration

1 Apply a small amount of cream to the affected area 2-3 times daily; 2 Ensure the skin in clean and dry before use; 3 For first-time users, perform a patch test on a small area of skin to check for sensitivity.

Description

Miconazole Nitrate 2%

Section 44425-7

Store in a cool, dry place.

Section 50565-1

Keep out of reach of children. In case of ingestion, seek medical help or contact a Poison Control Center immediately.

Section 50566-9

Irritation occurs or if there is no improvement within 4 weeks.

Section 50570-1

On children under 3 years of age.

Section 51727-6

Aqua, Stemona Japonica Root Extract, Dictamnus Dasycarpus Root Bark Extract, Sophora Flavescens Root Extract, Aloe Barbadensis Leaf Extract, Cnidium Monnieri Fruit Extract, Tocopherol, Borneol, Menthol, Stearic Acid, Petrolatum, Paraffinum Liquidum, Glycerin, Triethanolamine

Section 51945-4

Section 53413-1

Email at: [email protected]

Section 55105-1

Antifungal

Section 55106-9

Miconazole Nitrate 2%

Section 60561-8

Avoid contact with the eyes.


Structured Label Content

Indications and Usage (34067-9)

Anti-fungal for the effective treatment of Athlete's Foot, Jock Itch, Ringworm, Eczema, Tinea Versicolor, and fungal folliculitis.

Dosage and Administration (34068-7)

1 Apply a small amount of cream to the affected area 2-3 times daily; 2 Ensure the skin in clean and dry before use; 3 For first-time users, perform a patch test on a small area of skin to check for sensitivity.

Warnings and Precautions (34071-1)

For external use only

Section 44425-7 (44425-7)

Store in a cool, dry place.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of ingestion, seek medical help or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

Irritation occurs or if there is no improvement within 4 weeks.

Section 50570-1 (50570-1)

On children under 3 years of age.

Section 51727-6 (51727-6)

Aqua, Stemona Japonica Root Extract, Dictamnus Dasycarpus Root Bark Extract, Sophora Flavescens Root Extract, Aloe Barbadensis Leaf Extract, Cnidium Monnieri Fruit Extract, Tocopherol, Borneol, Menthol, Stearic Acid, Petrolatum, Paraffinum Liquidum, Glycerin, Triethanolamine

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Email at: [email protected]

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

Miconazole Nitrate 2%

Section 60561-8 (60561-8)

Avoid contact with the eyes.


Advanced Ingredient Data


Raw Label Data

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