FDA.reportPublic FDA data

Salicylic acid

Manufacturer
Chain Drug Consortium, LLC | Premier Brands of America | Alchemix Corporation
Effective date
2019-12-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:02:00

Label at a glance#

ProductSalicylic acid
Active ingredientSALICYLIC ACID
Label structure9 sections

Dosage and administration

wash affected area and dry area thoroughly if necessary, cut medicated patch to fit callus apply adhesive side down of medicated patch onto 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 corn is removed) may soak corn 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
  • if you have poor blood circulation
  • on irritated skin, on any area that is infected or reddened

​Stop use and ask a doctor

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 area thoroughly
  • if necessary, cut medicated patch to fit callus
  • apply adhesive side down of medicated patch onto 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 corn is removed)
  • may soak corn 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 Value

Extra Thick
CALLUS REMOVERS

Salicylic acid

  • Callus removal treatment
  • Relieves against pressure & pain

4 MEDICATED PATCHES/4 PADS

Premier Value_Extra Thick Callus Removers_LFCLRETPV.jpgPremier Value_Extra Thick Callus Removers_LFCLRETPV.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240559salicylic acid 40 % Medicated PatchPSN2
240559salicylic acid 0.4 MG/MG Medicated PatchSCD2
240559salicylic acid 40 % Medicated PatchSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-230-042021-07-23C16284748780-1c7ccaba7-199b-fd44-e053-dadaa90aa01bPremier Value Extra Thick Callus Removers

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-230-04Salicylic acid4 in 1 PACKAGEPATCH42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-230SALICYLIC ACID (MEDICATED CALLUS REMOVERS EXTRA THICK) PATCH [CHAIN DRUG CONSORTIUM, LLC]2Legacy NDC, 1 package rows20191213_f9939024-fdcb-42bd-9f25-b5bafa79a876.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
68016-23068016-230-04

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
SALICYLIC ACIDO414PZ4LPZACTIB
POLYVINYL ALCOHOL532B59J990IACT
VINYL ACETATEL9MK238N77IACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT

Source Document#

Source XML · Source PDF

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
489e1114-2f04-4f8d-b4d1-7b25022a587ef9939024-fdcb-42bd-9f25-b5bafa79a8762019-12-12WarningsExact identifier
spl id: 489e1114-2f04-4f8d-b4d1-7b25022a587e
spl set id: f9939024-fdcb-42bd-9f25-b5bafa79a876

Reported adverse events (FAERS/openFDA)#

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