Antifungal Treatment Liquid 25 undeclylenic Acid

Manufacturer
SANSAR, LLC | Fashion Pearlz LLP
Effective date
2025-04-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:58:31

Label at a glance#

ProductAntifungal Treatment Liquid 25 undeclylenic Acid
Active ingredientUNDECYLENIC ACID
Label structure6 sections

Indications and uses

For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis). For effective relief of itching, cracking, burning, redness, soreness, irritation and discomfort

Dosage and administration

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. 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. For athlete's foot and ringworm, use daily for 4 weeks; fo...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 25%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis).
  • For effective relief of itching, cracking, burning, redness, soreness, irritation and discomfort

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.
When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes.
Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs or if there is no improvement within 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

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. 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. For athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks.If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera Extract, Canola Oil, Clove Bud Oil, Lavender Oil, Manuka Oil, Oregano Oil, Peppermint Oil, Propolis Extract, Sweet Almond Oil, Tea Tree Oil, Tocopheryl Acetate

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package0Outer Package0Inner Package0Inner Package0

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998329undecylenic acid 25 % Topical SolutionPSN4
998329undecylenic acid 250 MG/ML Topical SolutionSCD4
998329undecylenic acid 25 % Topical SolutionSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83691-000-00Antifungal Treatment Liquid 25 undeclylenic Acid1 in 1 BOXLIQUID14
83691-000-00Antifungal Treatment Liquid 25 undeclylenic Acid15 mL in 1 BOTTLELIQUID154
83691-000-01Antifungal Treatment Liquid 25 undeclylenic Acid2 in 1 BOXLIQUID24
83691-000-01Antifungal Treatment Liquid 25 undeclylenic Acid15 mL in 1 BOTTLELIQUID154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83691-000ANTIFUNGAL TREATMENT LIQUID 25 UNDECLYLENIC ACID (UNDECYLENIC ACID) LIQUID [SANSAR, LLC]4Current NDC, 4 package rows20250406_2ae0f300-154e-44c8-bcc3-b5c334e661ac.zip

Products#

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

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83691-00083691-000-00, 83691-000-01

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

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
Antifungal Treatment Liquid 25 undeclylenic AcidUNDECYLENIC ACIDSANSAR, LLC2ae0f300-154e-44c8-bcc3-b5c334e661ac2025-04-02WarningsExact identifier
ndc (package): 83691-000-01
ndc (package): 83691-000-00
ndc (product): 83691-000
ndc11 (package): 83691000000
ndc11 (package): 83691000001
spl id: 2742c493-f552-4088-803f-ebe0286858ff
spl set id: 2ae0f300-154e-44c8-bcc3-b5c334e661ac

Reported adverse events (FAERS/openFDA)#

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