FDA.reportPublic FDA data

Kopa Haiku Antifungal Cream

Manufacturer
Trovina Co. Ltd | Jiangxi Zhongletang Pharmaceuticals Co., Ltd.
Effective date
2026-05-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:57:53

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 (Water), Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Eugenia Caryophyllus (Clove) Leaf Oil/Bud Oil, Aloe Barbadensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita (Matricaria) Flower Extract, Eucalyptus Globulus Leaf Oil, Macadamia Seed Oil, Safflower Seed Oil, Olive Fruit Oil, Avocado Oil, Sweet Almond Oil, Pumpkin Seed Oil, Geranium Flower Oil, Orange Peel Oil, Centella Asiatica (Cica), Tocopherol, Borneol, Menthol, Stearic Acid, Petrolatum, Paraffinum Liquidum, Glycerin, Triethanolamine

OTC - QUESTIONS SECTION

Email at: service@kopahaiku.co.uk

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0505

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998483miconazole nitrate 2 % Topical CreamPSN3
998483miconazole nitrate 20 MG/ML Topical CreamSCD3
998483miconazole nitrate 2 % Topical CreamSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MICONAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87041-004-01Kopa Haiku Antifungal Cream60 g in 1 CARTONCREAM603

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87041-00487041-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
ALOE BARBADENSIS LEAF POWDERZY81Z83H0XIACT
TOCOPHEROLR0ZB2556P8IACT
CENTELLA ASIATICA7M867G6T1UIACT
SAFFLOWER SEED OIL POLYGLYCERYL-6 ESTERSR2Z4507WJNIACT
ALMOND OIL66YXD4DKO9IACT
PUMPKIN SEED OIL6E5QR5USSPIACT
HYDROGENATED MACADAMIA SEED OILW4FFC8IM2KIACT
GLYCERINPDC6A3C0OXIACT
LAVANDULA ANGUSTIFOLIA (LAVENDER) OILZBP1YXW0H8IACT
AQUA059QF0KO0RIACT
EUGENIA CARYOPHYLLUS (CLOVE) LEAF OILVCA5491KVFIACT
STEARIC ACID4ELV7Z65APIACT
AVOCADO OIL6VNO72PFC1IACT
BORNEOLM89NIB437XIACT
EUGENIA CARYOPHYLLUS (CLOVE) BUD OIL578389D6D0IACT
GLYCYRRHIZA GLABRA (LICORICE) ROOT POWDER2788Z9758HIACT
ORANGE OILAKN3KSD11BIACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILVIF565UC2GIACT
CHAMOMILEFGL3685T2XIACT
PELARGONIUM GRAVEOLENS FLOWER OIL3K0J1S7QGCIACT
PARAFFINUM LIQUIDUMT5L8T28FGPIACT
TRIETHANOLAMINE9O3K93S3TKIACT
MENTHOLL7T10EIP3AIACT
EUCALYPTUS GLOBULUS LEAF OIL2R04ONI662IACT
OLIVE OIL6UYK2W1W1EIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-02-12monthly-update2026-06-03 17:56:30
12026-01-07monthly-update2026-06-03 17:52:48

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
Kopa Haiku Antifungal CreamMICONAZOLE NITRATE 2%Trovina Co. Ltd47cf1251-5965-045a-e063-6394a90ab04f2026-05-19WarningsExact identifier
ndc (package): 87041-004-01
ndc (product): 87041-004
ndc11 (package): 87041000401
spl id: 521a9be6-4f5a-2055-e063-6394a90a71c2
spl set id: 47cf1251-5965-045a-e063-6394a90ab04f

Reported adverse events (FAERS/openFDA)#

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