Salicylic Acid

Manufacturer: LEADER/ Cardinal Health 110, Inc.
Effective date: 2025-12-31
Label type: HUMAN OTC DRUG LABEL
Version: 16
Source: full-release
Hydrated at: 2026-06-01 01:29:44

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 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 callus is removed) may soak callus in warm water for 5 minutes to assist in removal

Contacts and useful links#

PhoneLabel contact1-866-964-0939

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 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 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

LEADER

Medicated

Callus

Removers
Salicylic Acid 40%

Effective Callus

Removal Treatment

Protect Against

Pressure and Pain

4 MEDICATED PATCHES 6 PROTECTIVE PADS

Leader Callus Remover

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
240559	salicylic acid 40 % Medicated Patch	PSN	16
240559	salicylic acid 0.4 MG/MG Medicated Patch	SCD	16
240559	salicylic acid 40 % Medicated Patch	SY	16

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70000-0333-1	2021-02-11	C162847	48780-1	ba0f9c33-2bc3-a910-e053-dadaa90a0b85	Leader Medicated Callus Removers
70000-0333-1	2021-02-11	C162847	48780-1	ba0f9c33-2bc3-a910-e053-dadaa90a0b85	Leader Medicated Callus Removers
70000-0333-1	2021-02-11	C162847	48780-1	ba0f9c33-2bc3-a910-e053-dadaa90a0b85	Leader Medicated Callus Removers

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70000-0333-1	Salicylic Acid	4 in 1 CARTON	PATCH	4		16
70000-0333-1	Salicylic Acid	1 g in 1 PATCH	PATCH	1		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70000-0333-1	EA - Each	70000-0333	ef601b1e-c831-4052-a1a0-dcea330e5089	1	2018-11-06

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

Salicylic Acid
Medicated Callus Removers
HIGH DENSITY POLYETHYLENE
POLYVINYL ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70000-0333	70000-0333-1

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
Name	UNII	Kind
HIGH DENSITY POLYETHYLENE	UG00KM4WR7	IACT
SALICYLIC ACID	O414PZ4LPZ	ACTIB
POLYVINYL ALCOHOL	532B59J990	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
14	2025-10-08	monthly-update	2026-06-03 17:37:57
13	2024-11-01	full-release	2026-06-01 00:32:55

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Salicylic Acid	MEDICATED CALLUS REMOVERS	LEADER/ Cardinal Health 110, Inc.	05c70325-4cd2-4e5a-b4f5-de5d7232eebc	2025-12-31	Warnings	Exact identifier ndc (package): 70000-0333-1 ndc (product): 70000-0333 ndc11 (package): 70000033301 spl id: 47442c07-26d8-9c58-e063-6394a90ae37a spl set id: 05c70325-4cd2-4e5a-b4f5-de5d7232eebc

Reported adverse events (FAERS/openFDA)#

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