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FDA Approval

Antifungal Ringworm Cream

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Jiangxi Yudexi Pharmaceutical Co., LTD
DUNS: 455662836
Effective Date
May 28, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Miconazole(0.1 g in 100 g)
menthol, unspecified form(8 g in 100 g)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Antifungal Ringworm Cream

Product Details

NDC Product Code
85248-007
Application Number
M005
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
TOPICAL
Effective Date
May 28, 2025
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4Class: IACT
LONICERA JAPONICA STEMInactive
Code: NW9XC3TM8RClass: IACT
CHRYSANTHEMUM INDICUM FLOWERInactive
Code: I6OER6U04LClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
PHELLODENDRON AMURENSE BARKInactive
Code: PBG27B754GClass: IACT
Code: 7NNO0D7S5MClass: ACTIBQuantity: 0.1 g in 100 g
CNIDIUM MONNIERI FRUITInactive
Code: V1IA3S3CUSClass: IACT
SOPHORA FLAVESCENS ROOTInactive
Code: IYR6K8KQ5KClass: IACT
PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT
LAUROCAPRAMInactive
Code: 1F3X9DRV9XClass: IACT
ALLANTOINInactive
Code: 344S277G0ZClass: IACT
DICTAMNUS DASYCARPUS ROOTInactive
Code: 6153LEN214Class: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
menthol, unspecified formActive
Code: L7T10EIP3AClass: ACTIBQuantity: 8 g in 100 g
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1SClass: IACT
CHLORHEXIDINE ACETATEInactive
Code: 5908ZUF22YClass: IACT
BASSIA SCOPARIA WHOLEInactive
Code: 240G38P85ZClass: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug facts

Drug Facts

Active ingredients Purpose

Menthol 8.0%…............................…………………..………………….Anti-Fungal
Miconazole 0.1%…............................…………….……..…………….Anti-Fungal

Uses

Targets Athletes Foot, Psoriasis, Eczema, Ringworm, and Fungal Infections. Relieves itching, irritation, redness, scaling and discomfort.

For external use only

Do not use on children under 3 years of age unless directed by a doctor.

When using this product avoid contact with eyes.

Stop and ask a doctor if - irritation occurs - there is no improvement within 4 weeks

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.

Warnings

Directions

  • Clean and dry the affected area.
  • Apply a thin layer of cream 3-4 times daily.
  • Use daily for 4 weeks.
  • If your condition persists, see a doctor.
  • This product is not effective on the scalp or nails. Avoid applying it to the face.

Other information

Store away from excess heat and direct sun.

Inactive ingredients

Chlorhexidine Diacetate, Sophora Angustifolia, Dictamnus Dasycarpus, Kochia Scoparia, Lonicera Japonica, Chrysanthemum Indicum, Phellodendron Amurense, Cnidii Fructus, Petroleum Jelly, Glycerol, Stearic Acid, Cetostearyl Alcohol, Azone, Allantoin, Glycerol Monostearate


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