NDC 49035-155 Salicylic Acid

Medicated Corn Removers

NDC Product Code 49035-155

NDC Product Information

Salicylic Acid with NDC 49035-155 is a a human over the counter drug product labeled by Wal-mart Stores Inc. The generic name of Salicylic Acid is medicated corn removers. The product's dosage form is patch and is administered via topical form.

Labeler Name: Wal-mart Stores Inc

Dosage Form: Patch - 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’.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Salicylic Acid Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SALICYLIC ACID 40 mg/91

Inactive Ingredient(s)

Additional informationCallout TooltipAbout the Inactive Ingredient(s)
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.

  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Wal-mart Stores Inc
Labeler Code: 49035
FDA Application Number: part358F Additional informationCallout TooltipWhat 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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. Additional informationCallout TooltipWhat 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.

Start Marketing Date: 03-15-2019 Additional informationCallout TooltipWhat is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 Additional informationCallout TooltipWhat is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N Additional informationCallout TooltipWhat 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Salicylic Acid Product Label Images

Salicylic Acid Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

Salicylic acid 40%

Purpose

Corn remover

Uses

  • For the removal of cornsrelieves pain by removing corns

Warnings

For external use only.

Do Not Use

  • If you are diabeticif you have poor blood circulationon irritated skin, on any area that is infected or reddened

Stop Use And Ask 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 thoroughlyif necessary, cut medicated patch to fit cornapply adhesive side of medicated patch onto corncover medicated patch with padafter 48 hours, remove medicated patchrepeat 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 Information

Store between 15° and 30°C (59° and 86°F)

Inactive Ingredients

Acrylic adhesive, acrylic polymer, polyethylene, polyvinyl alcohol

Questions?

1-888-287-1915

* Please review the disclaimer below.

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