FDA.reportPublic FDA data

Wart Remover Gel

Manufacturer
Premier Brands of America Inc.
Effective date
2025-04-15
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 00:59:15

Label at a glance#

ProductWart Remover Gel
Active ingredientSALICYLIC ACID
Label structure9 sections

Dosage and administration

after washing affected area, soak wart in for 5 minutes in comfortably warm water dry area thoroughly gently squeeze a drop of gel from tube and apply to wart. Apply one drop at a time to sufficiently cover each wart let dry repeat this procedure once or twice daily (until wart is removed) for up to 12 weeks

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.
  • 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 and 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
Do not use on

OTC - DO NOT USE SECTION

  • moles, birthmarks and warts with hair growing from them

  • mucous membranes such as nose, anus, genitals and lips
  • irritated, infected or reddened skin
  • genital warts and warts on the face
When using this product

OTC - WHEN USING SECTION

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

OTC - ASK DOCTOR SECTION

if discomforts persists see your doctor or podiatrist

​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

  • after washing affected area, soak wart in for 5 minutes in comfortably warm water
  • dry area thoroughly
  • gently squeeze a drop of gel from tube and apply to wart. Apply one drop at a time to sufficiently cover each wart
  • let dry
  • repeat this procedure once or twice daily (until wart is removed) for up to 12 weeks

Other information

OTHER SAFETY INFORMATION

store between 59°F to 86°F (15°C to 30°C)

​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

Fast Acting Gel

  • Removes common and plantar warts
  • Convenient & easy
  • No drip formula
  • Safe & Effective

Net Wt 0.25 OZ (7 g)

Gel Wart tubeGel Wart tube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312880salicylic acid 17 % Topical GelPSN11
312880salicylic acid 0.17 MG/MG Topical GelSCD11
312880salicylic acid 17 % Topical GelSY11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56104-237-07Wart Remover Gel7 g in 1 TUBEGEL711

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56104-237WART REMOVER GEL GEL [PREMIER BRANDS OF AMERICA INC.]11Current NDC, Legacy NDC, 1 package rows20250417_db4ba7ac-a58b-42d5-9181-da70309f1791.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ2
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
CAMPHOR (NATURAL)INACTIVE INGREDIENTN20HL7Q9412
ETHYL ACETATEINACTIVE INGREDIENT76845O8NMZ2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671P2
HYPOPHOSPHOROUS ACIDINACTIVE INGREDIENT8B1RL9B4ZJ2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H2
PYROXYLININACTIVE INGREDIENTKYR8BR2X6O2

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
56104-23756104-237-07

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 CELLULOSE (1600000 WAMW)RFW2ET671PIACT
POLYSORBATE 806OZP39ZG8HIACT
PYROXYLINKYR8BR2X6OIACT
SALICYLIC ACIDO414PZ4LPZACTIB

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
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PGEL / TOPICAL222 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HGEL / TOPICAL12 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ETHYL ACETATEETHYL ACETATE76845O8NMZSOLUTION / TOPICAL31 %w/wExact identifier — unii+route
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PGEL / TOPICAL222 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ETHYL ACETATEETHYL ACETATE76845O8NMZSOLUTION / TOPICAL31 %w/wExact identifier — unii+route
2 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HGEL / TOPICAL12 mgExact identifier — unii+route+dosage form
2 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
Wart Remover GelWART REMOVER GELPremier Brands of America Inc.db4ba7ac-a58b-42d5-9181-da70309f17912025-04-15WarningsExact identifier
ndc (package): 56104-237-07
ndc (product): 56104-237
ndc11 (package): 56104023707
spl id: 32d28d8e-c7ac-2e09-e063-6294a90aee0a
spl set id: db4ba7ac-a58b-42d5-9181-da70309f1791

Reported adverse events (FAERS/openFDA)#

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