455662836 by Jiangxi Yudexi Pharmaceutical Co., LTD 85248-135

455662836 by

Drug Labeling and Warnings

455662836 by is a Otc medication manufactured, distributed, or labeled by Jiangxi Yudexi Pharmaceutical Co., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

455662836- miconazole nitrate 2% antifungal cream 
Jiangxi Yudexi Pharmaceutical Co., LTD

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85248-135

Active Ingredient

Miconazole Nitrate 2% w/w

Purpose

Antifungal

Use

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

Warnings

For external use only.

Do not use

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

When Using

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

Irritation occurs Condition persists for more than 2 weeks or worsens

Ask Doctor

Irritation occurs Condition persists for more than 2 weeks or worsens

Keep Oot Of Reach Of Children

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

Directions

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

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

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

455662836 
miconazole nitrate 2% antifungal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85248-135
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BORNEOL (UNII: M89NIB437X)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
LEVOMENTHOL (UNII: BZ1R15MTK7)
STEARIC ACID (UNII: 4ELV7Z65AP)
EUPHORBIA HIRTA (UNII: L13YF113GN)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
STEMONA TUBEROSA ROOT (UNII: 7S9328671Z)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
ALOE (UNII: V5VD430YW9)
ORIGANUM DICTAMNUS FLOWERING TOP (UNII: 9RBR98LSD9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85248-135-01	100 g in 1 BOTTLE; Type 0: Not a Combination Product	02/10/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	02/10/2026	02/14/2026

Labeler - Jiangxi Yudexi Pharmaceutical Co., LTD (455662836)

Revised: 2/2026

Document Id: 4ac11eb9-ac30-f1cb-e063-6294a90aa63a

34390-5

Set id: 4a7037fd-b16c-1f57-e063-6294a90a2bab

Version: 2

Effective Time: 20260213