KOPA HAIKU ANTIFUNGAL SOAP.- tolnaftate 1% soap

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Tolnaftate 1%

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

on children under 2 years of age except under the advice and supervision of a doctor.

When using this product avoid contact with the eyes.

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.

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

QUESTIONS

service@kopahaiku.co.uk

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KOPA HAIKU ANTIFUNGAL SOAP. 
tolnaftate 1% soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87041-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
STEARIC ACID (UNII: 4ELV7Z65AP)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
EUCALYPTUS GLOBULUS LEAF OIL (UNII: 2R04ONI662)
LAURIC ACID (UNII: 1160N9NU9U)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)
OLEA EUROPAEA (OLIVE) FRUIT OIL (UNII: 6UYK2W1W1E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)
ELAEIS GUINEENSIS (PALM) OIL (UNII: 5QUO05548Z)
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87041-007-01	125 g in 1 CARTON; Type 0: Not a Combination Product	05/15/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	05/15/2026

Labeler - Trovina Co. Ltd (233813758)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Zhongletang Pharmaceuticals Co., Ltd.		411295811	manufacture(87041-007)