455662836

Manufacturer
Jiangxi Yudexi Pharmaceutical Co., LTD
Effective date
2026-02-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:34:06

Label at a glance#

Product455662836
Active ingredientMICONAZOLE NITRATE
Label structure13 sections

Dosage and administration

Clean the affected area and dry thoroughly. Apply a thin layer to the affected area twice daily (morning and night). Supervise children in the use of this product. Use daily for the full treatment period as directed. This product is not effective on the scalp or nails.

Storage and handling

1. Keep in a cool and dry place, avoid direct sunlight. 2. Keep out of the reach of children to avoid accidental ingestion.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2% w/w

Purpose

OTC - PURPOSE SECTION

Antifungal

Use

INDICATIONS & USAGE SECTION

Helps relieve the itching, burning, cracking, and scaling associated with fungal infections such as athlete's foot,jock itch, and ringworm.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

you are allergic to miconazole or any of the ingredients in this product

When Using

OTC - WHEN USING SECTION

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Do not use on children under 2 years of age unless directed by a doctor.

Stop Use

OTC - STOP USE SECTION

Irritation occurs Condition persists for more than 2 weeks or worsens

Ask Doctor

OTC - ASK DOCTOR SECTION

Irritation occurs Condition persists for more than 2 weeks or worsens

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Clean the affected area and dry thoroughly. Apply a thin layer to the affected area twice daily (morning and night). Supervise children in the use of this product. Use daily for the full treatment period as directed. This product is not effective on the scalp or nails.

Other information

STORAGE AND HANDLING SECTION

1. Keep in a cool and dry place, avoid direct sunlight. 2. Keep out of the reach of children to avoid accidental ingestion.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe, Borneol, Cnidium, Dictamnus, Euphorbia, Glycerin, Light liquid paraffin, Medical petrolatum, Natural menthol, Purified water, Sophora Flavescens, Stearic acid, Stemona, Triethanolamine, Vitamin E

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

22

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85248-13585248-135-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4ac11eb9-ac30-f1cb-e063-6294a90aa63a4a7037fd-b16c-1f57-e063-6294a90a2bab2026-02-13WarningsExact identifier
spl set id: 4a7037fd-b16c-1f57-e063-6294a90a2bab

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.