Premier Brands Anti-Fungal Nail Solution Pen

Manufacturer
Premier Brands of America Inc.
Effective date
2024-02-01
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:11:58

Label at a glance#

ProductUndecylenic Acid Liquid
Active ingredientUNDECYLENIC ACID
Label structure9 sections

Indications and uses

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

Dosage and administration

​Read all warnings and directions. Use only as directed. ​ clean the affected area and dry thoroughly twist and click pen untill product is dispensed onto the tip of the applicator. Initial use will require several clicks apply a thin layer of the product over the 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 a...

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

For relief of:

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

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
  • twist and click pen untill product is dispensed onto the tip of the applicator. Initial use will require several clicks
  • apply a thin layer of the product over the 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. 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)
  • protect from freezing. If freezing occurs, warm to room temperature
  • keep tightly closed when not in use

​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

Maximum Strength

ANTI-FUNGAL PEN

​Undecylenic Acid 25%

Eliminates fungus

on fingers, toes &

around nails

Pre-filled pen

with applicator

brush

Convenient &

easy to use

Non-oily formula

dries quickly

NET CONTENTS 0.05 FL OZ (1.7 mL)

nail pen 1nail pen 1

nail pen 2nail pen 2

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
56104-24156104-241-05

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

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
115f001d-3e7a-1378-e063-6294a90a7183b5e4d930-9b71-0a7a-e053-2a95a90a84d12024-02-14WarningsExact identifier
spl set id: b5e4d930-9b71-0a7a-e053-2a95a90a84d1

Reported adverse events (FAERS/openFDA)#

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