FDA.reportPublic FDA data

Kopa Haiku Antifungal Cream

Manufacturer
Trovina Co. Ltd | Jiangxi Zhongletang Pharmaceuticals Co., Ltd.
Effective date
2026-02-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:56:26

Label at a glance#

ProductKopa Haiku Antifungal Cream
Active ingredientMICONAZOLE NITRATE
Label structure9 sections

Storage and handling

Store in a cool, dry place.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

OTC - PURPOSE SECTION

Antifungal

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

On children under 3 years of age.

OTHER SAFETY INFORMATION

Avoid contact with the eyes.

OTC - STOP USE SECTION

Irritation occurs or if there is no improvement within 4 weeks.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of ingestion, seek medical help or contact a Poison Control Center immediately.

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87041-00387041-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-11-18monthly-update2026-06-03 17:40:23

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
5175891b-d8ce-bd71-e063-6294a90afd7343cd6784-62ab-8323-e063-6294a90ab2b62026-05-10WarningsExact identifier
spl set id: 43cd6784-62ab-8323-e063-6294a90ab2b6

Reported adverse events (FAERS/openFDA)#

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