SPL v2
SPL
SPL Set ID 47cf1251-5965-045a-e063-6394a90ab04f
Route
TOPICAL
Published
Effective Date 2026-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (20 mg)
Inactive Ingredients
Orange Oil Petrolatum Aloe Barbadensis Leaf Powder Tocopherol Centella Asiatica Safflower Seed Oil Polyglyceryl-6 Esters Almond Oil Pumpkin Seed Oil Hydrogenated Macadamia Seed Oil Glycerin Lavandula Angustifolia (lavender) Oil Aqua Eugenia Caryophyllus (clove) Leaf Oil Stearic Acid Avocado Oil Borneol Eugenia Caryophyllus (clove) Bud Oil Glycyrrhiza Glabra (licorice) Root Powder Melaleuca Alternifolia (tea Tree) Leaf Oil Chamomile Pelargonium Graveolens Flower Oil Paraffinum Liquidum Triethanolamine Menthol Eucalyptus Globulus Leaf Oil Olive Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-15

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 (Water), Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Eugenia Caryophyllus (Clove) Leaf Oil/Bud Oil, Aloe Barbadensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita (Matricaria) Flower Extract, Eucalyptus Globulus Leaf Oil, Macadamia Seed Oil, Safflower Seed Oil, Olive Fruit Oil, Avocado Oil, Sweet Almond Oil, Pumpkin Seed Oil, Geranium Flower Oil, Orange Peel Oil, Centella Asiatica (Cica), 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 (Water), Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Eugenia Caryophyllus (Clove) Leaf Oil/Bud Oil, Aloe Barbadensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita (Matricaria) Flower Extract, Eucalyptus Globulus Leaf Oil, Macadamia Seed Oil, Safflower Seed Oil, Olive Fruit Oil, Avocado Oil, Sweet Almond Oil, Pumpkin Seed Oil, Geranium Flower Oil, Orange Peel Oil, Centella Asiatica (Cica), 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

All Sections (JSON)