FDA.reportPublic FDA data

Salicylic Acid

Manufacturer
Family Dollar Services Inc.
Effective date
2024-05-02
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:03:57

Label at a glance#

ProductSalicylic Acid
Active ingredientSALICYLIC ACID
Label structure9 sections

Indications and uses

for removal of calluses relieves pain by removing calluses

Dosage and administration

wash affected area and dry thoroughly if necessary, cut medicated patch to fit callus apply adhesive side 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 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

Uses

INDICATIONS & USAGE SECTION

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

Ask your 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 thoroughly
  • if necessary, cut medicated patch to fit callus
  • apply adhesive side 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 callus is removed)
  • may soak callus in warm water for 5 minutes to assist in removal

Other information

OTHER SAFETY INFORMATION

store between 15° and 30°C (59° 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

FAMILY wellness

MEDICATED

Callus REMOVERS

salicylic acid

  • Effective Callus Removal Treatment
  • Protects Against Pressure & Friction

4 MEDICATED PATCHES/ 6PADS

callus removercallus remover

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55319-184-042023-01-31C16284748780-1f386c649-aea5-0266-e053-dadaa90a7c1aFamily Dollar Medicated Callus Removers
55319-184-042023-01-30C16284748780-1f386c649-aea5-0266-e053-dadaa90a7c1aFamily Dollar Medicated Callus Removers

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
55319-18455319-184-04

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
POLYVINYL ALCOHOL532B59J990IACT
VINYL ACETATEL9MK238N77IACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
SALICYLIC ACIDO414PZ4LPZACTIB

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
17e140fe-4411-d30f-e063-6294a90aae46f23cd551-a881-40e6-a282-4c6cabf9f16a2024-05-07WarningsExact identifier
spl set id: f23cd551-a881-40e6-a282-4c6cabf9f16a

Reported adverse events (FAERS/openFDA)#

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