FDA.reportPublic FDA data

Antifungal Medicated Bar - Haikou Pucao Trading Co.,Ltd

Manufacturer
Haikou Pucao Trading Co.,Ltd
Effective date
2026-03-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:59:04

Label at a glance#

ProductAntifungal Medicated Bar
Active ingredientTOLNAFTATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

OTC - PURPOSE SECTION

anti-fungal

INDICATIONS & USAGE SECTION

Cures & prevents most athlete's foot(tinea pedis), jock itch(tinea cruris) & ringworm (tinea corporis).
Relieves itching, irritation, redness, scaling, and discomfort associated with these conditions.

WARNINGS SECTION

Forx external use only

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

avoid contact with the eyes. If contact occurs, rinse the eyes thoroughly with water.

OTC - STOP USE SECTION

if condition worsens or does not improve after 4 weeks of regular use as directed.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Wash the affected area thoroughly with water.
Lather the soap and apply it to the affected area.
Allow the lather to sit on the skin for 2-3 minutes before rinsing thoroughly.
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.
Use 1-2 times daily for 4 weeks; if the condition persists longer, consult a doctor.
Supervise children in the use of this product.

OTHER SAFETY INFORMATION

Store at room temperature.
Protect from freezing.

INACTIVE INGREDIENT SECTION

Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aqua (Water), Sorbitol, Elaeis Guineensis (Palm) Oil, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Propylene Glycol, Glycerin, Stearic Acid, Lauric Acid, Myristic Acid, Sodium Myristate, Sodium Glutamate, Sodium Hydroxide, Sodium Dodecylbenzene Sulfonate, Sulfur, Hamamelis Virginiana (Witch Hazel) Extract, Ceramide NP.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

antifungal soapantifungal soap

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codeqrco.de/bfpUEIantifungal soap.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85261-00185261-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILVIF565UC2GIACT
OLEA EUROPAEA (OLIVE) FRUIT OIL6UYK2W1W1EIACT
WATER059QF0KO0RIACT
CERAMIDE NP4370DF050BIACT
SULFUR70FD1KFU70IACT
SORBITOL506T60A25RIACT
LAURIC ACID1160N9NU9UIACT
ELAEIS GUINEENSIS (PALM) OIL5QUO05548ZIACT
TOLNAFTATE06KB629TKVACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM HYDROXIDE55X04QC32IIACT
GLYCERINPDC6A3C0OXIACT
SODIUM DODECYLBENZENESULFONATE554127163YIACT
SODIUM MYRISTATE06BLC4V0IVIACT
SODIUM GLUTAMATEW81N5U6R6UIACT
COCOS NUCIFERA (COCONUT) OILQ9L0O73W7LIACT
STEARIC ACID4ELV7Z65APIACT
MYRISTIC ACID0I3V7S25AWIACT
HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF WATER8FP93ED6H2IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4df0dcc5-c72d-505d-e063-6394a90a94fd313162be-c33b-7790-e063-6394a90a32162026-03-26WarningsExact identifier
spl id: 4df0dcc5-c72d-505d-e063-6394a90a94fd
spl set id: 313162be-c33b-7790-e063-6394a90a3216

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.