NDC 49035-162 Salicylic Acid

One Step Clear Medicated Corn Remover

NDC Product Code 49035-162

NDC Product Information

Salicylic Acid with NDC 49035-162 is a a human over the counter drug product labeled by Wal-mart Stores Inc. The generic name of Salicylic Acid is one step clear medicated corn remover. 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/81

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.

  • BROWN IRON OXIDE (UNII: 1N032N7MFO)
  • 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 Ingredient

Salicylic acid 40% w/w

Purpose

Corn remover

Use

For the removal of corns

Warnings

For external use only.

Do Not Use

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

Keep Out Of Reach Of Children

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

If Discomfort Persists

See your doctor or podiatrist.

Directions

  • Wash affected area, may soak corn in warm water for 5 minutesdry area thoroughlyremove bandage strips by peeling backing off at slitadhere medicated bandage directly over cornafter 48 hours remove medicated bandage striprepeat this procedure every 48 hours as needed (until corn is removed) for up to 14 days

Other Information

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

Inactive Ingredients

Acrylic adhesive, brown iron oxide, polyethylene foam

Questions?

1-888-287-1915

* Please review the disclaimer below.

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