Drug labels

Fungicure Anti-Fungal Wash

SEPIA · Kobayashi Healthcare International, Inc. · TOPICAL

HUMAN OTC DRUG
Open FDA's page for this record
Set ID
ba0cea2d-23ee-4725-abcf-72a62ad58176
ID
5517de4d-43c6-82d3-e063-6394a90ab351
Effective time
20261030
Version
13
SPL product data elements

Fungicure Anti-Fungal Wash Sepia LAURAMIDOPROPYL BETAINE PANTHENOL LECITHIN, SOYBEAN WATER SODIUM CHLORIDE SODIUM C14-16 OLEFIN SULFONATE TEA TREE OIL SEPIA OFFICINALIS JUICE SEPIA OFFICINALIS JUICE

Active ingredient
Active ingredient Sepia 12x
Purpose
Purpose Antifungal treatment
Indications and usage

Uses For the treatment of most jock itch (tinea cruris) ringworm (tinea corporis) athlete's foot (tinea pedis) tinea versicolor For relief of: itching scaling cracking burning redness soreness irritation discomforts which may accompany these conditions.

Warnings
Warnings For external use only
Ask doctor
Ask a doctor before use on children under 2 years of age.
When using
When using this product avoid contact with the eyes. If contact occurs rinse thoroughly with water.
Stop use
Stop use and ask a doctor if irritation occurs there is no improvement within 2 weeks (4 weeks for ringworm, athlete's foot and tinea versicolor).
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 and administration

Directions Read all package directions and warnings before use. Use only as directed. Clean the affected area with Fungicure Anti-Fungal Wash and warm water, rinse and dry thoroughly. For best results, leave on for 1-2 minutes before rinsing and drying. Use twice daily (morning and night), or as directed by a doctor. This product is not effective on scalp or nails. For jock itch, use daily for 2 weeks. For ringworm, tinea versicolor and athlete's foot, use daily for 4 weeks. If condition persists longer, consult a doctor. 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. Intended for use by normally healthy adults only. Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor. Supervise children in the use of this product.

Information for patients
Other information You may report serious side effects to the phone number provided under Questions? below.
Inactive ingredient
Inactive ingredients Lauramidopropyl betaine, panthenol, phospholipid EFA, purified water, sodium chloride, sodium C14 - 16 olefin sulfonate, tea tree oil.
Questions
Questions? 1-800-792-2582
Package label principal display panel
PDP
Harmonized identifiers (openFDA)
Brand name
Fungicure Anti-Fungal Wash
Generic name
SEPIA
Manufacturer name
Kobayashi Healthcare International, Inc.
Product NDC
52389-226
Product type
HUMAN OTC DRUG
Route
TOPICAL
Substance name
SEPIA OFFICINALIS JUICE
SPL ID
5517de4d-43c6-82d3-e063-6394a90ab351
SPL set ID
ba0cea2d-23ee-4725-abcf-72a62ad58176
Package NDC
52389-226-06
Is original packager
true
UNII
QDL83WN8C2
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.