Otc - Active Ingredient
Tolnaftate 1%
Kopa Haiku Antifungal Soap. Soap
FDA Label NDC 87041-007
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 Soap. (NDC 87041-007). 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
Proven clinically effective in treatment of most athlete's foot (tinea pedis), ringworm (tinea corporis), and jock itch (tinea cruris).
For effective relief of itching, burning, and cracking skin
Warnings
For external use only
Otc - Do Not Use
on children under 2 years of age except under the advice and supervision of a doctor.
Other Safety Information
When using this product avoid contact with the eyes.
Otc - Stop Use
If irritation occurs or if there is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot and ringworm.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contract a Poison Control Center right away.
Dosage & Administration
1 Wash the affected area well and let the product sit 1-2 minutes before rinsing.
2 Make sure to dry the affected area thoroughly.
3 Supervise children in the use of this product.
4 For an athlete's foot: pay special attention to the spaces between the toes. Wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
5 Use 1-2 times daily. Use daily for 4 weeks. If the condition persists longer, ask a doctor.
6 This product is not effective on the scalp and nails.
Storage And Handling
Store in a cool, dry place.
Inactive Ingredient
SORBITOL, PROPYLENE GLYCOL, TEARIC ACID, LAURIC ACID, SUCROSE, GLYCERIN, WATER, ELAEIS GUINEENSIS (PALM) OIL, BUTYROSPERMUM PARKII (SHEA) BUTTER, OLEA EUROPAEA (OLIVE) FRUIT OIL, SODIUM HYDROXIDE, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, CAMELLIA JAPONICA SEED OIL, EUCALYPTUS GLOBULUS LEAF OIL, SOPHORA FLAVESCENS EXTRACT, FRAGRANCE
Otc - Questions
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