SPL v3
SPL
SPL Set ID 450dab4d-168a-60b8-e063-6394a90ab303
Route
TOPICAL
Published
Effective Date 2025-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (20 mg)
Inactive Ingredients
Aqua Menthol Eucalyptus Globulus Leaf Oil Eugenia Caryophyllus (clove) Leaf Oil Eugenia Caryophyllus (clove) Bud Oil Borneol Petrolatum Triethanolamine Lavandula Angustifolia (lavender) Oil Matricaria Chamomilla Whole Aloe Barbadensis Leaf Glycyrrhiza Glabra (licorice) Root Paraffinum Liquidum Glycerin Tocopherol Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-09

Description

MICONAZOLE NITRATE 2%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

For the effective treatment of jock itch (tinea cruris), athlete’s foot (tinea pedis), ringworm (tinea corporis), and other common fungal skin infections.

Dosage and Administration

1. Apply a small amount of cream to the affected area 2–3 times daily. 2. Make sure the skin is clean and dry before application. 3. For first-time users, perform a patch test on a small area of skin to check for sensitivity.

Description

MICONAZOLE NITRATE 2%

Section 50565-1

If swallowed, get medical help immediately.

Section 50566-9

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

Section 50567-7

Avoid contact with the eyes

Section 50569-3

You have concerns about skin irritation or if symptoms persist beyond 4 weeks.

Section 50570-1

On children under 3 years of age

Section 51727-6

Aqua (Water), Lavandula Angustifolia (Lavender) Oil, Eugenia Caryophyllus (Clove) Leaf/Bud Oil, Aloe Barbadensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita (Matricaria) Flower Extract, Eucalyptus Globulus Leaf Oil, Tocopherol, Borneol, Menthol, Stearic Acid, Petrolatum, Paraffinum Liquidum, Glycerin, Triethanolamine.

Section 51945-4

Section 53413-1

Please contact the email: [email protected]

Section 55105-1

Antifungal

Section 55106-9

MICONAZOLE NITRATE 2%

Section 60561-8

Store in a cool, dry place


Structured Label Content

Indications and Usage (34067-9)

For the effective treatment of jock itch (tinea cruris), athlete’s foot (tinea pedis), ringworm (tinea corporis), and other common fungal skin infections.

Dosage and Administration (34068-7)

1. Apply a small amount of cream to the affected area 2–3 times daily. 2. Make sure the skin is clean and dry before application. 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 50565-1 (50565-1)

If swallowed, get medical help immediately.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

Avoid contact with the eyes

Section 50569-3 (50569-3)

You have concerns about skin irritation or if symptoms persist beyond 4 weeks.

Section 50570-1 (50570-1)

On children under 3 years of age

Section 51727-6 (51727-6)

Aqua (Water), Lavandula Angustifolia (Lavender) Oil, Eugenia Caryophyllus (Clove) Leaf/Bud Oil, Aloe Barbadensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita (Matricaria) Flower Extract, Eucalyptus Globulus Leaf Oil, Tocopherol, Borneol, Menthol, Stearic Acid, Petrolatum, Paraffinum Liquidum, Glycerin, Triethanolamine.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Please contact the email: [email protected]

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

MICONAZOLE NITRATE 2%

Section 60561-8 (60561-8)

Store in a cool, dry place


Advanced Ingredient Data


Raw Label Data

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