84558-025

Manufacturer
GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd
Effective date
2026-07-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-07-21 05:10:25

Label at a glance#

Product2% MICONAZOLE NITRATE ANTIFUNGAL Cream
Active ingredientMICONAZOLE NITRATE
Label structure12 sections

Dosage and administration

Clean and dry the affected area thoroughly. Apply a thin layer twice daily (morning and night). Athlete's foot /ringworm: use for 4 weeks. Jock itch: use for 2 weeks. Supervise children during use; wear well-ventilated shoes and change socks daily for athlete's foot.

Storage and handling

Store at 20°-25C(68°-77°F). Do not use if carton or inner seal is broken.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

Purpose

OTC - PURPOSE SECTION

Antifungal

Use

INDICATIONS & USAGE SECTION

Treats athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm
(tinea corporis).Relieves itching, scaling, burning and discomfort.

Warnings

WARNINGS SECTION

For external use only. Avoid contact with eyes. Do not use on children
under 2 years of age unless directed by a doctor. Do not use for vaginal
yeast infections.
Ask a doctor before use if you have diabetes, immune system problems,
or a condition covering more than half the affected area.
Stop use and ask a doctor if irritation occurs, condition worsens, or there
is no improvement within 2 weeks (jock itch) or 4 weeks (athlete's
foot /ringworm).
Keep out of reach of children. If swallowed, get medical help or contact
Poison Control right away.

Do not use

OTC - DO NOT USE SECTION

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

Do not use for vaginal yeast infections.

OTC - WHEN USING SECTION

avoid contact with eyes
do not apply to irritated or broken skin
use only as directed

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation occurs, condition worsens, or there
is no improvement within 2 weeks (jock itch) or 4 weeks (athlete's
foot /ringworm).

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact
Poison Control right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Clean and dry the affected area thoroughly. Apply a thin layer twice daily (morning and night).
Athlete's foot /ringworm: use for 4 weeks.
Jock itch: use for 2 weeks.
Supervise children during use; wear well-ventilated shoes and change socks daily for athlete's foot.

Other information

STORAGE AND HANDLING SECTION

Store at 20°-25C(68°-77°F). Do not use if carton or inner seal is broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Caprylic/Capric Triglyceride, Propylene Glycol,Stearic
Acid, C12-15Alkyl Benzoate, Glyceryl Stearate,Cetyl Alcohol,
Dimethicone, Phenoxyethanol, Squalane, PEG-100 Stearate,
Triethanolamine, Panthenol, Centella Asiatica Extract, Camellia Sinensis
Leaf Extract, Curcuma Longa Root Extract,Sophora Flavescens Root
Extract, Phellodendron Amurense Bark Extract, Pseudolarix Amabilis Root
Bark Extract,Kochia Scoparia Fruit Extract,Eugenia Caryophyllus (Clove)
Bud Extract, Melaleuca Alternifolia Leaf Oil, Allantoin,Carbomer,Bisabolol,
Beta-Glucan,Aloe Barbadensis Leaf Juice,Tocopheryl Acetate,
Ethylhexylglycerin, Disodium EDTA,Ceramide NP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84558-02584558-025-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 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
2% MICONAZOLE NITRATE ANTIFUNGAL Cream2% MICONAZOLE NITRATE ANTIFUNGAL CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd56b54359-db21-b8b4-e063-6394a90a6f8c2026-07-16WarningsExact identifier
ndc (package): 84558-025-01
ndc (product): 84558-025
ndc11 (package): 84558002501
spl id: 56b54364-9b5d-b864-e063-6394a90aed25
spl set id: 56b54359-db21-b8b4-e063-6394a90a6f8c

Reported adverse events (FAERS/openFDA)#

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