Salicylic Acid

Manufacturer: Hudson Health LLC
Effective date: 2021-07-20
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 23:41:36

Label at a glance#

ProductSalicylic Acid

Active ingredientSALICYLIC ACID

Label structure9 sections

Indications and uses

for the removal of calluses relieves pain by removing calluses

Dosage and administration

wash affected area and dry thoroughlyif 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 contact1-877-237-0194

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 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

Stop use and ask a doctor 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 thoroughlyif 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 1-877-237-0194

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

comfortzone

medicated

callus remvoers

salicylic acid

effective callus removal treatment
protects against pressure & friction

12 pads/ 8 medicated patches

Amazon_Callus Removers_52-005AM.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
240559	salicylic acid 40 % Medicated Patch	PSN	4
240559	salicylic acid 0.4 MG/MG Medicated Patch	SCD	4
240559	salicylic acid 40 % Medicated Patch	SY	4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72446-001-08	2023-01-30	C162847	48780-1	f386c649-ae13-0266-e053-dadaa90a7c1a	Comfortzone Medicated Callus Removers

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72446-001-08	Salicylic Acid	8 in 1 PACKAGE	PATCH	8		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72446-001	SALICYLIC ACID (MEDICATED CALLUS REMOVERS) PATCH [HUDSON HEALTH LLC]	4	Legacy NDC, 1 package rows	20210721_fee137cf-48c0-4b62-b3e4-59acd504f5c3.zip

Products#

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

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

Salicylic Acid
Medicated Callus Removers
POLYVINYL ALCOHOL, UNSPECIFIED
VINYL ACETATE
HIGH DENSITY POLYETHYLENE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
72446-001	72446-001-08

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
Name	UNII	Kind
POLYVINYL ALCOHOL, UNSPECIFIED	532B59J990	IACT
VINYL ACETATE	L9MK238N77	IACT
HIGH DENSITY POLYETHYLENE	UG00KM4WR7	IACT
SALICYLIC ACID	O414PZ4LPZ	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
c793393d-8514-2558-e053-2995a90a4a38			fee137cf-48c0-4b62-b3e4-59acd504f5c3	2021-07-20	Warnings	Exact identifier spl id: c793393d-8514-2558-e053-2995a90a4a38 spl set id: fee137cf-48c0-4b62-b3e4-59acd504f5c3

Reported adverse events (FAERS/openFDA)#

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