85248-204update

Manufacturer
Jiangxi Yudexi Pharmaceutical Co., LTD
Effective date
2026-07-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-07-23 05:10:04

Label at a glance#

ProductKakalsa TOENAIL FUNGUS TREATMENT
Active ingredientUNDECYLENIC ACID
Label structure13 sections

Dosage and administration

For athlete's foot and ringworm: use daily for 4 weeks. 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. This product is not effective for the treatment of ring worm of the scalp or nails. For athlete's foot: pay special attention to spaces between the toes, wea...

Storage and handling

Store at 15°–30° (59°–86°F) and out of direct sunlight.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 25%

Purpose

OTC - PURPOSE SECTION

Antifungal

Use

INDICATIONS & USAGE SECTION

Cures most Athlete's Foot (Tinea Pedis) and Ringworm (Tinea Corporis). Relieves itching, scaling, cracking, burning, redness, soreness, and irritation and discomfort. Helps prevent most athlete's foot (dermatophytosis) with daily use.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

·On children under 2 years of age unless directed by a doctor.
·If you're pregnant, breastfeeding, or any allergic reaction occurs.

When Using

OTC - WHEN USING SECTION

·Avoid contact with eyes.
·If contact occurs, immediately rinse thoroughly with water or seek medical advice if necessary.

Stop Use

OTC - STOP USE SECTION

·Irritation occurs.
·No improvement if you have persisted in using it for 4 weeks.

Ask Doctor

OTC - ASK DOCTOR SECTION

·Irritation occurs.
·No improvement if you have persisted in using it for 4 weeks.

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

For athlete's foot and ringworm:
use daily for 4 weeks. 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. This product is not effective for the treatment of ring worm of the scalp or nails.
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. To prevent athlete's foot, apply once or twice daily (morning and/or night). Apply to skin around the nail and cuticle.

Other information

STORAGE AND HANDLING SECTION

Store at 15°–30° (59°–86°F) and out of direct sunlight.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Aloe Vera Extract, Tea Tree Oil, Clove Bud Oil, Lavender Oil, Jojoba Oil, Manuka Oil, Peppermint Oil, Oregano Leaf Oil, Propolis, Almond Oil, Alpha-Tocopherol, Acetate (Vitamin E).

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2525

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85248-20485248-204-01, 85248-204-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-05-06full-release2026-06-01 01:56:16

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
Kakalsa TOENAIL FUNGUS TREATMENTUNDECYLENIC ACID 25% TOENAIL FUNGUS TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD5123c0c3-bba8-d61c-e063-6394a90aab702026-07-20WarningsExact identifier
ndc (package): 85248-204-02
ndc (package): 85248-204-01
ndc (product): 85248-204
ndc11 (package): 85248020402
ndc11 (package): 85248020401
spl id: 5716c502-8465-c29e-e063-6394a90a963b
spl set id: 5123c0c3-bba8-d61c-e063-6394a90aab70

Reported adverse events (FAERS/openFDA)#

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