Otc - Active Ingredient
Miconazole nitrate 2%
Kopa Haiku Ringworm Treatment Cream
FDA Label NDC 87041-008
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 Ringworm Treatment Cream (NDC 87041-008). 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
For effective treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).
Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort, and chafing associated with jock itch.
Warnings
For external use only.
Otc - Do Not Use
on children under 2 years of age unless directed by a doctor.
Other Safety Information
avoid contact with the eyes.
Otc - Stop Use
Irritation occurs.
There is no improvement within 4 weeks for athlete's foot and ringworm.
There is no improvement within 2 weeks for jock itch.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
■ clean the affected area and dry thoroughly ■ apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor ■ supervise children in the use of this product ■ for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily ■ for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks ■ if condition persists longer, consult a doctor ■ this product is not effective on the scalp or nails
Storage And Handling
Store in a cool, dry environment.
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]
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