FDA.reportPublic FDA data

Undecylenic Acid Liquid

Manufacturer
Premier Brands of America Inc.
Effective date
2024-02-14
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:11:24

Label at a glance#

ProductUndecylenic Acid Liquid
Active ingredientUNDECYLENIC ACID
Label structure9 sections

Indications and uses

For cure of most tinea pedis (athlete's foot) and tinea corporis (ringworm). ​ For relief of : itching burning redness irritation scaling soreness discomfort which may accompany these conditions

Dosage and administration

​Read all warnings and directions. Use only as directed. ​ clean the affected area and dry thoroughly apply a thin layer of the product over the affecter 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 toes wear well-fitting, ventilated shoes, and change shoes and socks at least once daily for ...

Label contents#

Full prescribing information#

​Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic acid 25%w/w

​Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

For cure of most tinea pedis (athlete's foot) and tinea corporis (ringworm). ​

For relief of:

  • itching
  • burning
  • redness
  • irritation
  • scaling
  • soreness
  • discomfort which may accompany these conditions

Warnings

WARNINGS SECTION

For external use only

OTC - PREGNANCY OR BREAST FEEDING SECTION

  consult a healthcare professional before use.

Do not use

OTC - DO NOT USE SECTION

​on children 2 years of age unless directed by a doctor.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes

Use only as directed

INSTRUCTIONS FOR USE SECTION

​by a doctor on persons with highly sensitive skin.

Stop use and consult a doctor if

OTC - STOP USE SECTION

  • there is no improvement within 4 weeks
  • irritation occurs

Keep out of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

​If accidental ingestion occurs, get medical help or contact a Poison Control Center right away.

​Directions

DOSAGE & ADMINISTRATION SECTION

​Read all warnings and directions. Use only as directed.​

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product over the affecter 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 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. If conditions persists longer, consult a doctor
  • this product is not effective on the scalp or nails

​Other information​

OTHER SAFETY INFORMATION

  • store at room temperature 15°-30°C (59° - 86°F)

​Inactive ingredient

INACTIVE INGREDIENT SECTION

isopropyl palmitate

Questions?

OTC - QUESTIONS SECTION

Call 1-866-964-0939

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

​Premier Brands

Maximum Strength

Anti-Fungal Liquid

​25% Undecylenic acid

Eliminates fungus on fingers, toes and around nails.

​Easy to apply applicator brush

Dries quickly

Non-oily, clear formula

No unpleasant odor

Net Contents: 1 FL OZ (30 mL)

PB Anti-Fungal Nail Solution Liquid Box.jpgPB Anti-Fungal Nail Solution Liquid Box.jpgPB Anti-Fungal Nail Solution Liquid Label.jpgPB Anti-Fungal Nail Solution Liquid Label.jpg

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
UNDECYLENIC ACIDACTIVE INGREDIENTK3D86KJ24N1
UNDECYLENIC ACIDACTIVE MOIETYK3D86KJ24N1
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63M1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
56104-11456104-114-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL PALMITATE8CRQ2TH63MIACT
UNDECYLENIC ACIDK3D86KJ24NACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 8 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MOINTMENT / TOPICALNAExact identifier — unii candidate
8 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MAEROSOL, SPRAY / TOPICAL397 mgExact identifier — unii candidate
8 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MGEL / TOPICALNAExact identifier — unii candidate
8 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MAEROSOL / TOPICAL397 mgExact identifier — unii candidate
8 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MFILM, EXTENDED RELEASE / TRANSDERMAL187.5 mgExact identifier — unii candidate
8 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MCREAM / TOPICAL112 mgExact identifier — unii candidate
8 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MFILM / TRANSDERMAL2 mgExact identifier — unii candidate
8 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MLOTION / TOPICAL5 %w/wExact identifier — unii candidate
8 equally ranked IID candidates

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
115cf201-cfec-9b69-e063-6294a90aba64e1b40b6a-2de3-4f07-883f-0ab6dbf6238d2024-02-14WarningsExact identifier
spl id: 115cf201-cfec-9b69-e063-6294a90aba64
spl set id: e1b40b6a-2de3-4f07-883f-0ab6dbf6238d

Reported adverse events (FAERS/openFDA)#

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