32396be0-f74a-5483-e063-6294a90ab3ae

SPL v1
SPL
SPL Set ID 32396be0-f74a-5483-e063-6294a90ab3ae
Route
topical
Published
Effective Date 2025-04-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
miconazole (15 mg)
Inactive Ingredients
cnidium monnieri fruit stemona japonica root smilax glabra tuber gleditsia sinensis fruit mentha canadensis top

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-04-22

Description

Miconazole Nitrate


Medication Information

Warnings and Precautions

For external use only

Active Ingredient

Miconazole Nitrate

Indications and Usage

Helps soothe and care for skin affected by folliculitis.

Supports relieffrom itching, irritation, redness, scaling, and general skin discomfort.

Dosage and Administration

-Wash the affected area and dry thoroughly.

-Apply a thin layer over the affected area twice daily (morning and night) or

as directed by a doctor.

-Supervise children in the use of this produc

-lf the condition persists, consult a doctor.

Description

Miconazole Nitrate

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if Irritation occurs. There is no improvement within

4 weeks. Discomfort persists.

Section 50567-7

Avoid contact with eyes.

If contact occurs, rinse thoroughly with water.

Section 50570-1

Do not use On children under 2 years of age unless directed by a doctor.

Section 51727-6

Ingredients:Cnidium Monnieri Fruit, Gleditsia Sinensis Lam.

Typhonium Giganteum Whole, Stemona Japonica Root,

Smilax Glabra Roxb. Borneolum Syntheticum [chp],

Mentha Canadensis [who-dd], Equally extracted herbal extracts

Section 51945-4

Section 53413-1
Section 55105-1

Antifungal

Section 60561-8

Store at 59-86°F (15-30°C). Close the cap tightly after use.


Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Active Ingredient (55106-9)

Miconazole Nitrate

Indications and Usage (34067-9)

Helps soothe and care for skin affected by folliculitis.

Supports relieffrom itching, irritation, redness, scaling, and general skin discomfort.

Dosage and Administration (34068-7)

-Wash the affected area and dry thoroughly.

-Apply a thin layer over the affected area twice daily (morning and night) or

as directed by a doctor.

-Supervise children in the use of this produc

-lf the condition persists, consult a doctor.

Section 50565-1 (50565-1)

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 Irritation occurs. There is no improvement within

4 weeks. Discomfort persists.

Section 50567-7 (50567-7)

Avoid contact with eyes.

If contact occurs, rinse thoroughly with water.

Section 50570-1 (50570-1)

Do not use On children under 2 years of age unless directed by a doctor.

Section 51727-6 (51727-6)

Ingredients:Cnidium Monnieri Fruit, Gleditsia Sinensis Lam.

Typhonium Giganteum Whole, Stemona Japonica Root,

Smilax Glabra Roxb. Borneolum Syntheticum [chp],

Mentha Canadensis [who-dd], Equally extracted herbal extracts

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)
Section 55105-1 (55105-1)

Antifungal

Section 60561-8 (60561-8)

Store at 59-86°F (15-30°C). Close the cap tightly after use.


Advanced Ingredient Data


Raw Label Data

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