Otc - Active Ingredient
Miconazole Nitrate 2%
Kopa Haiku Antifungal Cream
FDA Label NDC 87041-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trovina Co. Ltd for the product Kopa Haiku Antifungal Cream (NDC 87041-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, other safety information, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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
Otc - Do Not Use
On children under 3 years of age.
Other Safety Information
Avoid contact with the eyes.
Otc - Stop Use
Irritation occurs or if there is no improvement within 4 weeks.
Otc - Keep Out Of Reach Of Children
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
Otc - Questions
Email at: [email protected]
Package Label.Principal Display Panel
Package (Photo 2025 11 18 10 34 19)
* Please review the disclaimer below.
