FDA.reportPublic FDA data

Salicylic acid

Manufacturer
Premier Brands of America Inc.
Effective date
2024-10-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:52:38

Label at a glance#

ProductSalicylic acid
Active ingredientSALICYLIC ACID
Label structure9 sections

Dosage and administration

wash affected area and dry thoroughly if necessary, cut medicated patch to fit callus carefully adhere medicated patch directly over callus cover medicated patch with pad after 48 hours, remove medicated patch repeat procedure every 48 hours as needed for up to 14 days (until callus is removed) may soak callus in warm water for 5 minutes to assist in removal

Label contents#

Full prescribing information#

​Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 40%

Purpose

OTC - PURPOSE SECTION

Callus remover

Use

INDICATIONS & USAGE SECTION

  • for the removal of calluses
  • relieves pain by removing calluses

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • if you are a diabetic
  • have poor blood circulation
  • on irritated skin, on any area that is infected or reddened

OTC - ASK DOCTOR SECTION

If 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 and dry thoroughly
  • if necessary, cut medicated patch to fit callus
  • carefully adhere medicated patch directly over callus
  • cover medicated patch with pad
  • after 48 hours, remove medicated patch
  • repeat procedure every 48 hours as needed for up to 14 days (until callus is removed)
  • may soak callus in warm water for 5 minutes to assist in removal

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylic adhesive, acrylic polymer, polyethylene, polyvinyl alcohol

Questions?

OTC - QUESTIONS SECTION

call 1-866-964-0939

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Premier

CALLUS REMOVERS

Salicylic Acid

Effective callus removal treatment

Protects against pressure & friction

MEDICATED

6 PADS/4 MEDICATED PATCHES

image 1image 1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56104-244SALICYLIC ACID (CALLUS REMOVERS) PATCH [PREMIER BRANDS OF AMERICA INC.]4Legacy NDC20241016_e192e81a-b7f9-3461-e053-2995a90a7e2c.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
56104-24456104-244-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYVINYL ALCOHOL532B59J990IACT
VINYL ACETATEL9MK238N77IACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
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
3bba69a2-c7c8-e420-e063-6294a90a8741e192e81a-b7f9-3461-e053-2995a90a7e2c2025-08-06WarningsExact identifier
spl set id: e192e81a-b7f9-3461-e053-2995a90a7e2c

Reported adverse events (FAERS/openFDA)#

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