FDA.reportPublic FDA data

Salicylic Acid

Manufacturer
Premier Brands of America Inc.
Effective date
2024-10-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:52:40

Label at a glance#

ProductSalicylic Acid
Active ingredientSALICYLIC ACID
Label structure9 sections

Dosage and administration

wash affected area. may soak corn in warm water for 5 minutes. dry area thoroughly if necessary, cut medicated disc to fit the wart. carefully apply the medicated with sticky side onto the wart. cover the medicated disc with the center of the bandage strip. 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 40% w/w

Purpose

OTC - PURPOSE SECTION

Wart remover

Use

INDICATIONS & USAGE SECTION

  • For the removal of warts. The common wart is easily recognized by the rough 'cauliflower-like' appearance of the surface.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • if you are a diabetic
  • if you have poor blood circulation
  • on irritated skin or any area that is infected or reddened
  • on genital warts or warts on the face
  • on moles, birthmarks and warts with hair growing from them
  • on mucous membranes such as nose, anus, genitals and lips

Stop use and ask 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • wash affected area.
  • may soak corn in warm water for 5 minutes.
  • dry area thoroughly
  • if necessary, cut medicated disc to fit the wart.
  • carefully apply the medicated with sticky side onto the wart.
  • cover the medicated disc with the center of the bandage strip.
  • 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° and 86°F (15° and 30°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylic adhesive, polyethylene foam.

Questions?

OTC - QUESTIONS SECTION

Call 1-866-964-0939

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Premier Solutions

Medicated Clear

Wart Removers

SALICYLIC ACID 40%

MAXIMUM

STRENGTH

  • Safely removes common & plantar warts
  • Conceals & protects
  • Medicated disc, no-mess application

18 MEDICATED DISCS | 14 CLEAR STRIPS

Image 1Image 1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56104-259SALICYLIC ACID (CLEAR MEDICATED CORN REMOVERS) PATCH [PREMIER BRANDS OF AMERICA INC.]3Unmatched20241016_f5628216-774a-0695-e053-2995a90ae3f5.zip

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
56104-25956104-259-01

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
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
VINYL ACETATEL9MK238N77IACT
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
400edc31-522f-b0ca-e063-6294a90afc49f5628216-774a-0695-e053-2995a90ae3f52025-09-30WarningsExact identifier
spl set id: f5628216-774a-0695-e053-2995a90ae3f5

Reported adverse events (FAERS/openFDA)#

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