FDA Label for Kopa Haiku Antifungal Cream
View Indications, Usage & Precautions
Kopa Haiku Antifungal Cream Product Label
The following document was submitted to the FDA by the labeler of this product Trovina Co. Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Miconazole Nitrate 2%
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.
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
Storage And Handling
Store in a cool, dry place.
Otc - Questions
Email at: [email protected]
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