Otc - Active Ingredient
Miconazole Nitrate 2%
Kopa Haiku Antifungal Cream
FDA Label NDC 87041-004
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 87041-004). 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 (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
Email at: [email protected]
Package Label.Principal Display Panel
Package (Kh Plant Based Antifungal 60g Packaging Drugfacts Outlined 02)
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