431483f6-2386-9f5c-e063-6294a90af104

Set ID
431483f6-2386-9f5c-e063-6294a90af104
Manufacturer
Trovina Co. Ltd | Jiangxi Zhongletang Pharmaceuticals Co., Ltd.
Effective date
2026-02-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:44:11

Key Label Information

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

Anti-fungal for the effective treatment of Athlete's Foot, Jock Itch, Ringworm, Eczema, Tinea Versicolor, and fungal folliculitis.

Warnings

WARNINGS SECTION

For external use only

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

1 Apply a small amount of cream to the affected area 2-3 times daily; 2 Ensure the skin in clean and dry before use; 3 For first-time users, perform a patch test on a small area of skin to check for sensitivity.

Other Label Information

STORAGE AND HANDLING SECTION

Store in a cool, dry place.

INACTIVE INGREDIENT SECTION

Aqua, Stemona Japonica Root Extract, Dictamnus Dasycarpus Root Bark Extract, Sophora Flavescens Root Extract, Aloe Barbadensis Leaf Extract, Cnidium Monnieri Fruit Extract, Tocopherol, Borneol, Menthol, Stearic Acid, Petrolatum, Paraffinum Liquidum, Glycerin, Triethanolamine

OTC - QUESTIONS SECTION

Email at: service@kopahaiku.co.uk

Products

NDC Codes

Ingredients

NameUNIIKind
STEMONA JAPONICA ROOTFXG254HF10IACT
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KIACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB
TRIETHANOLAMINE9O3K93S3TKIACT
AQUA059QF0KO0RIACT
PETROLATUM4T6H12BN9UIACT
ALOE BARBADENSIS LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
STEARIC ACID4ELV7Z65APIACT
BORNEOLM89NIB437XIACT
PARAFFINUM LIQUIDUMT5L8T28FGPIACT
CNIDIUM MONNIERI FRUITV1IA3S3CUSIACT
MENTHOLL7T10EIP3AIACT
DICTAMNUS DASYCARPUS ROOT BARKLA97176ILSIACT
TOCOPHEROLR0ZB2556P8IACT

Complete SPL Sections

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Antifungal

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

Anti-fungal for the effective treatment of Athlete's Foot, Jock Itch, Ringworm, Eczema, Tinea Versicolor, and fungal folliculitis.

WARNINGS SECTION

WARNINGS SECTION

For external use only

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

1 Apply a small amount of cream to the affected area 2-3 times daily; 2 Ensure the skin in clean and dry before use; 3 For first-time users, perform a patch test on a small area of skin to check for sensitivity.

STORAGE AND HANDLING SECTION

STORAGE AND HANDLING SECTION

Store in a cool, dry place.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Aqua, Stemona Japonica Root Extract, Dictamnus Dasycarpus Root Bark Extract, Sophora Flavescens Root Extract, Aloe Barbadensis Leaf Extract, Cnidium Monnieri Fruit Extract, Tocopherol, Borneol, Menthol, Stearic Acid, Petrolatum, Paraffinum Liquidum, Glycerin, Triethanolamine

OTC - QUESTIONS SECTION

OTC - QUESTIONS SECTION

Email at: service@kopahaiku.co.uk

Source Document

Official SPL XML cached by FDA.report ยท DailyMed PDF

XML object
dailymed/431483f6-2386-9f5c-e063-6294a90af104/4a9fbe97-6b77-2709-e063-6294a90a009a.xml
XML SHA-256
e2b7f609c21597a21b5335e3403501a82b6ba9b0f7b19f8a939485734ef73ece
XML bytes
19383

Legacy File Index

FolderFileDate
otc4a9fbe97-6b77-2709-e063-6294a90a009a.xml2026-02-14
otc431483f6-2387-9f5c-e063-6294a90af104.xml2025-11-15
otcIMG_20251110_164143_375.jpg2025-11-15