FDA.reportPublic FDA data

Salicylic Acid

Manufacturer
Premier Brands of America Inc.
Effective date
2026-01-09
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 01:34:06

Label at a glance#

ProductSalicylic Acid
Active ingredientSALICYLIC ACID
Label structure10 sections

Dosage and administration

after washing affected area, soak wart for 5 minutes in comfortably warm water dry area thoroughly if necessary, cut medicated patch to fit wart apply adhesive side down of patch onto wart cover patch with pad to conceal area repeat this procedure every 48 hours as needed (until wart is removed) for up to 12 weeks

Label contents#

Full prescribing information#

​Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid

Purpose

OTC - PURPOSE SECTION

Wart removal

Use

INDICATIONS & USAGE SECTION

For the removal of common warts. The common wart has a rough 'cauliflower-like' appearance.

Warnings

WARNINGS SECTION

For external use only.

Do not use this product if

OTC - DO NOT USE SECTION

  • 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

  • irritated, infected or reddened skin
  • moles, birthmarks and warts with hair growing from them
  • genital warts and warts on face
  • mucous membranes

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.

Stop and ask a doctor

OTC - ASK DOCTOR SECTION

If discomfort persists see your doctor or podiatrist

Directions

DOSAGE & ADMINISTRATION SECTION

  • after washing affected area, soak wart for 5 minutes in comfortably warm water
  • dry area thoroughly
  • if necessary, cut medicated patch to fit wart
  • apply adhesive side down of patch onto wart
  • cover patch with pad to conceal area
  • repeat this procedure every 48 hours as needed (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

rubber-based adhesive

Questions?

OTC - QUESTIONS SECTION

call 1-866-964-0939

RECENT MAJOR CHANGES SECTION

..

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Premier

Maximum Strength

Wart Removers

Medicated

Salicylic Acid

  • Patch/Pad method covers and removes wart
  • No messy liquids
  • Safe and effective

18 Medicated Patches/20 Pads

PREMIER_Wart Remover_BOX_WRBP-1-01.jpgPREMIER_Wart Remover_BOX_WRBP-1-01.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240559salicylic acid 40 % Medicated PatchPSN13
240559salicylic acid 0.4 MG/MG Medicated PatchSCD13
240559salicylic acid 40 % Medicated PatchSY13

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56104-017-18Salicylic Acid18 in 1 BOXPATCH1813

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR71
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J9901
VINYL ACETATEINACTIVE INGREDIENTL9MK238N771

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
56104-01756104-017-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYVINYL ALCOHOL532B59J990IACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
SALICYLIC ACIDO414PZ4LPZACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
122025-10-31monthly-update2026-06-03 17:38:36
112025-06-21full-release2026-06-01 01:03:39

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 · 14 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7CREAM / TOPICAL54.5 %w/wExact identifier — unii+route
10 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7CREAM / TOPICAL54.5 %w/wExact identifier — unii+route
10 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7GEL / TOPICAL26 %w/wExact identifier — unii+route
10 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7TAPE / TOPICALNAExact identifier — unii+route
10 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7PASTE / TOPICAL2.5 %w/wExact identifier — unii+route
10 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7PASTE / TOPICAL2.5 %w/wExact identifier — unii+route
10 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990SOLUTION / TOPICAL1.4 %w/vExact identifier — unii+route
4 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7OINTMENT / TOPICAL94 %w/wExact identifier — unii+route
10 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990SOLUTION / TOPICAL1.4 %w/vExact identifier — unii+route
4 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990SYSTEM / TOPICAL420 mgExact identifier — unii+route
4 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990SYSTEM / TOPICAL420 mgExact identifier — unii+route
4 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7OINTMENT / TOPICAL94 %w/wExact identifier — unii+route
10 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7GEL / TOPICAL26 %w/wExact identifier — unii+route
10 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7TAPE / TOPICALNAExact identifier — unii+route
10 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
Salicylic AcidWART REMOVERSPremier Brands of America Inc.ec588377-e672-4960-a3ca-2286f72ef5a52026-01-09WarningsExact identifier
ndc (package): 56104-017-18
ndc (product): 56104-017
ndc11 (package): 56104001718
spl id: 476e735c-4f3a-b6c4-e063-6394a90a8c2b
spl set id: ec588377-e672-4960-a3ca-2286f72ef5a5

Reported adverse events (FAERS/openFDA)#

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