SPL v2
SPL
SPL Set ID 3c28a93a-dd42-65b8-e063-6294a90ae6ab
Route
TOPICAL
Published
Effective Date 2026-02-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (20 mg)
Inactive Ingredients
Clove Oil Tocopherol Aqua Aloe Vera Leaf Oil Stearic Acid Menthol Borneol Tea Tree Oil Matricaria Recutita Flowering Top Petrolatum Paraffinum Liquidum Glycerin Eucalyptus Globulus Leaf Oil Triethanolamine Licorice Lavender Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-02-13
Description

Miconazole Nitrate 2%

Medication Information

Warnings and Precautions

For external use only

Indications and Usage

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.

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 50565-1

Keep Out of Reach of Children

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, 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 59845-8

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

Structured Label Content

Indications and Usage (34067-9)

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.

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 50565-1 (50565-1)

Keep Out of Reach of Children

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, 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 59845-8 (59845-8)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:54.450712 · Updated: 2026-03-14T23:13:40.815212