SPL v1
SPL
SPL Set ID 31abdc68-5027-15e7-e063-6394a90ac4e6
Route
TOPICAL
Published
Effective Date 2025-04-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (20 mg)
Inactive Ingredients
Euphorbia Hirta Artemisia Caruifolia Leaf Stemona Sessilifolia Root Viola Philippica Whole Sophora Flavescens Root Tea Tree Oil Murraya Paniculata Root Bark Phellodendron Chinense Whole Mentha Canadensis Top Smilax Glabra Tuber Mosla Cavaleriei Whole Stellera Chamaejasme Whole Cnidium Monnieri Fruit Bassia Scoparia Fruit Dictamnus Albus Root Bark Gleditsia Sinensis Fruit

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-22

Description

Miconazole Nitrate


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

-Treats fungal infections of the skin, such as jock itch (tinea cruris), athlete's foot (tinea pedis), and

ringworm (tinea corporis).

-Helps relieve itching redness, burning, and irritation caused by fungal

infections.

-Provides soothing comfort and supports skin recovery in areas prone to moisture and friction,

such as the groin, inner thighs, and body folds.

Dosage and Administration

1. Adults and children 12 years and over:

-Clean and dry the affected area before application.

-Apply a thin layer of cream to the affected area twice

daily (morning and night).

-Continue use for up to 2 weeks or as directed by a doctor.

Wear loose-fitting clothing to help keep the area dry.

2. Children under 12 years:

Ask a doctor before use.

Description

Miconazole Nitrate

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if: əlrritation or rash develops.

The condition worsens or does not improve within 2 weeks of regular use.

Section 50567-7

When using this product: Avoid contact with eyes.

If contact occurs, rinse thoroughly with water. Keep affected area clean and dry for best results.

Section 50570-1

Do not use: On broken, inflamed, or severely irritated skin.

lf you are allergic to Miconazole Nitrate or any of the ingredients in this product.

Section 51727-6



Herba Violae,

Euphorbia hirta,

Murraya paniculata,

Mentha canadensis,

Sophora flavescens,

Dittany Bark,

Glabrous Greenbrier Rhizome,

Mosla cavaleriei Levl,

Stellera chamaejasme,

Tea Tree Oil,

Artemisia Extract,

Huang Bai,

Sessile Stemona Root,

Gleditsia sinensis,

Common Cnidium Fruit,

Fructus Kochiae

Section 51945-4

Section 53413-1

Questions or comments?

Contact us at: [email protected]

Section 53414-9

If pregnant or breastfeeding, ask a healthcare provider before use.

Section 55105-1

Antifungal

Section 55106-9

Miconazole Nitrate

Section 60561-8

store at 20°C to 25°C (68°F-77°F).

see the top panel for lot number and expiration date.


Structured Label Content

Indications and Usage (34067-9)

-Treats fungal infections of the skin, such as jock itch (tinea cruris), athlete's foot (tinea pedis), and

ringworm (tinea corporis).

-Helps relieve itching redness, burning, and irritation caused by fungal

infections.

-Provides soothing comfort and supports skin recovery in areas prone to moisture and friction,

such as the groin, inner thighs, and body folds.

Dosage and Administration (34068-7)

1. Adults and children 12 years and over:

-Clean and dry the affected area before application.

-Apply a thin layer of cream to the affected area twice

daily (morning and night).

-Continue use for up to 2 weeks or as directed by a doctor.

Wear loose-fitting clothing to help keep the area dry.

2. Children under 12 years:

Ask a doctor before use.

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if: əlrritation or rash develops.

The condition worsens or does not improve within 2 weeks of regular use.

Section 50567-7 (50567-7)

When using this product: Avoid contact with eyes.

If contact occurs, rinse thoroughly with water. Keep affected area clean and dry for best results.

Section 50570-1 (50570-1)

Do not use: On broken, inflamed, or severely irritated skin.

lf you are allergic to Miconazole Nitrate or any of the ingredients in this product.

Section 51727-6 (51727-6)



Herba Violae,

Euphorbia hirta,

Murraya paniculata,

Mentha canadensis,

Sophora flavescens,

Dittany Bark,

Glabrous Greenbrier Rhizome,

Mosla cavaleriei Levl,

Stellera chamaejasme,

Tea Tree Oil,

Artemisia Extract,

Huang Bai,

Sessile Stemona Root,

Gleditsia sinensis,

Common Cnidium Fruit,

Fructus Kochiae

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Contact us at: [email protected]

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a healthcare provider before use.

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

Miconazole Nitrate

Section 60561-8 (60561-8)

store at 20°C to 25°C (68°F-77°F).

see the top panel for lot number and expiration date.


Advanced Ingredient Data


Raw Label Data

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