FDA.reportPublic FDA data

Premier Wart Remover Gel Pen

Manufacturer
Premier Brands of America, Inc.
Effective date
2021-01-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:54:31

Label at a glance#

ProductSalicylic Acid
Active ingredientSALICYLIC ACID
Label structure9 sections

Dosage and administration

wash affected area may soak wart in for 5 minutes dry area thoroughly remove cap from pen twist and click pen until wart remover gel is dispense onto the tip of the applicator. Initial use will require several rotations for the gel to load apply a small amount at a time with applicator to sufficiently cover each wart let dry repeat this procedure once or twice daily as needed (until wart is removed) for up to 12 w...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 17%w/w

Purpose

OTC - PURPOSE SECTION

Wart remover

Use

INDICATIONS & USAGE SECTION

  • for the removal of common and plantar warts. The common wart is easily recognized by the rough 'cauliflower-like' appearance of the surface
  • the plantar wart is recognized by its location only on the bottom of the foot, its tenderness and the interruption of the footprint pattern

Warnings

WARNINGS SECTION

For external use only.

Flammable

SAFE HANDLING WARNING SECTION

  • keep away from fire or flame

​Do not use

OTC - DO NOT USE SECTION

  • if you are a diabetic or have poor blood circulation, except under the advice and supervision of a doctor or podiatrist

  • on moles, birthmarks and warts with hair growing from them

  • on mucous membranes

  • on irritated, infected or reddened skin

  • on genital warts and warts on the face

​Ask doctor before use if you have:

OTC - ASK DOCTOR SECTION

  • diabetes
  • poor blood circulation

​When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes
  • if product gets into the eyes, flush with water for 15 minutes
  • avoid inhaling vapors

​Stop use and consult a doctor if

OTC - STOP USE SECTION

discomfort persists

​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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • wash affected area
  • may soak wart in for 5 minutes
  • dry area thoroughly
  • remove cap from pen
  • twist and click pen until wart remover gel is dispense onto the tip of the applicator. Initial use will require several rotations for the gel to load
  • apply a small amount at a time with applicator to sufficiently cover each wart
  • let dry
  • repeat this procedure once or twice daily as needed (until wart is removed) for up to 12 weeks
  • for storage ensure applicator is free of excess gel before placing the insert pin back into the tip

Other information

OTHER SAFETY INFORMATION

  • store between 59°F to 86°F (15°C to 30°C)
  • if gel hardens at tip of applicator, dispense product and remove blockage

​Inactive ingredients

INACTIVE INGREDIENT SECTION

camphor, castro oil, ethyl acetate, hydroxypropyl cellulose, hypophosphorous acid, isopropyl alcohol, nitrocellulose, polysorbate 80, SDA 3C ethyl alcohol

Questions?

OTC - QUESTIONS SECTION

Call 1-866-964-0939

​Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Premier


Maximum Strength
WART

REMOVER

GEL PEN

Salicylic Acid 17%

  • Safely removes common & plantar warts
  • Convenient & easy-to-use
  • No-drip, gel formula

1 PREFILLED APPLICATOR PEN

NET WT 0.04 OZ (1.25g)

wart remover gel pen 1wart remover gel pen 1

wart remover gel pen 2wart remover gel pen 2

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
56104-24056104-240-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (NATURAL)N20HL7Q941IACT
ALCOHOL3K9958V90MIACT
ETHYL ACETATE76845O8NMZIACT
HYPOPHOSPHOROUS ACID8B1RL9B4ZJIACT
HYDROXYPROPYL CELLULOSERFW2ET671PIACT
POLYSORBATE 806OZP39ZG8HIACT
PYROXYLINKYR8BR2X6OIACT
SALICYLIC ACIDO414PZ4LPZACTIB

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
c74098ec-eec6-9044-e053-2995a90a9686b5c5826c-44d3-a26d-e053-2995a90ad7282021-07-16WarningsExact identifier
spl set id: b5c5826c-44d3-a26d-e053-2995a90ad728

Reported adverse events (FAERS/openFDA)#

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