KOPA HAIKU ANTIFUNGAL CREAM- miconazole nitrate 2% cream

Kopa Haiku Antifungal Cream by

Drug Labeling and Warnings

Kopa Haiku Antifungal Cream by is a Otc medication manufactured, distributed, or labeled by Trovina Co. Ltd, Jiangxi Hemei Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Miconazole Nitrate 2%

PURPOSE

Antifungal

INDICATIONS & USAGE

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

WARNINGS

For external use only

On children under 3 years of age.

Avoid contact with the eyes.

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

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

DOSAGE & ADMINISTRATION

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

Store in a cool, dry place.

INACTIVE INGREDIENT

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

QUESTIONS

Email at: service@kopahaiku.co.uk

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KOPA HAIKU ANTIFUNGAL CREAM 
miconazole nitrate 2% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87041-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
STEMONA JAPONICA ROOT (UNII: FXG254HF10)
CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
GLYCERIN (UNII: PDC6A3C0OX)
DICTAMNUS DASYCARPUS ROOT BARK (UNII: LA97176ILS)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
AQUA (UNII: 059QF0KO0R)
ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)
PETROLATUM (UNII: 4T6H12BN9U)
TOCOPHEROL (UNII: R0ZB2556P8)
BORNEOL (UNII: M89NIB437X)
PARAFFINUM LIQUIDUM (UNII: T5L8T28FGP)
STEARIC ACID (UNII: 4ELV7Z65AP)
MENTHOL (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87041-003-01	60 g in 1 CARTON; Type 0: Not a Combination Product	11/19/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	11/19/2025

Labeler - Trovina Co. Ltd (233813758)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Hemei Pharmaceutical Co., Ltd		724892056	manufacture(87041-003)