NDC 79481-0593 Medicated Callus Removers
Salicylic Acid Patch Topical

Product Information

What is NDC 79481-0593?

The NDC code 79481-0593 is assigned by the FDA to the product Medicated Callus Removers which is a human over the counter drug product labeled by Meijer Distribution Inc.. The generic name of Medicated Callus Removers is salicylic acid. The product's dosage form is patch and is administered via topical form. The product is distributed in a single package with assigned NDC code 79481-0593-1 4 patch in 1 package . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code79481-0593
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Medicated Callus Removers
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		Salicylic Acid
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.		Human Otc Drug
Dosage FormPatch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Meijer Distribution Inc.
Labeler Code79481
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.		part358F
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.		OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		02-22-2023
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.		12-31-2024
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		N
NDC Code Structure

What are the uses for Medicated Callus Removers?


Product Packages

NDC Code 79481-0593-1

Package Description: 4 PATCH in 1 PACKAGE

Product Details

What are Medicated Callus Removers Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • SALICYLIC ACID 40 mg/41 - A compound obtained from the bark of the white willow and wintergreen leaves. It has bacteriostatic, fungicidal, and keratolytic actions.

Medicated Callus Removers Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Medicated Callus Removers Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

* Please review the disclaimer below.

Medicated Callus Removers Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredient



Salicylic acid 40%


Purpose



Callus remover


Uses



  • for removal of calluses
  • relieves pain by removing calluses

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

Ask Your Doctor



if discomfort persists.


Keep Out Of Reach Of Children.



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


Directions



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



store between 15°C to 30°C (59° to 86°F)


Inactive Ingredients



acrylic adhesive, acrylic polymer, polyethylene, polyvinyl alcohol


Questions?



call 1-866-964-0939


Principal Display Panel



Kroger

Medicated

callus remover

SALICYLIC ACID 40%

Maximum Strength

  • Effective Callus Remover Treatment
  • Protects Against Pressure & Friction

    • 6 PADS

    4 MEDICATED PATCHES


* Please review the disclaimer below.