MedPath

Salicylic Acid

Caring Mill Medicated Corn Removers

Approved
Approval ID

3cd17f19-6e54-a618-e063-6394a90abba4

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 19, 2025

Manufacturers
FDA

FSA Store Inc.

DUNS: 049283340

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Medicated Corn Remover

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code81522-910
Application NumberM030
Product Classification
M
Marketing Category
C200263
G
Generic Name
Medicated Corn Remover
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 19, 2025
FDA Product Classification

INGREDIENTS (4)

HIGH DENSITY POLYETHYLENEInactive
Code: UG00KM4WR7
Classification: IACT
SALICYLIC ACIDActive
Quantity: 400 mg in 1 g
Code: O414PZ4LPZ
Classification: ACTIB
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
VINYL ACETATEInactive
Code: L9MK238N77
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 4/30/2025

Principal Display Panel

caring mill

Medicated

Corn

Removers

Salicylic Acid 40% / Corn Remover

Maxium Strength

  • Effective corn removal treatment
  • Cushions against pressure & friction

9 Medicated Patches / 9 Pads

carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/19/2017

Uses

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 10/19/2017

Active Ingredient

Salicylic Acid 40%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 10/19/2017

Purpose

Corn Remover

WARNINGS SECTION

LOINC: 34071-1Updated: 8/13/2025

Warnings

For external use only

Do not use

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

Stop use and ask a doctor if

discomfort persists

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 4/29/2025

Directions

  • wash affected area and dry thoroughly
  • if necessary, cut medicated patch to fit corn
  • carefully adhere medicated patch directly over corn
  • 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 SAFETY INFORMATION

LOINC: 60561-8Updated: 10/19/2017

Other information

  • store between 15° and 30°C (59° and 86°F)
  • avoid surrounding skin when applying medicated patch

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 10/19/2017

Inactive ingredients

acrylic adhesive, acrylic polymer, polyethylene, polyvinyl alcohol

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 10/19/2017

Questions?

call 1-866-964-0939

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 4/30/2025

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.