NDC 51511-596 Salicylic Acid Wart Remover
Salicylic Acid Strip Topical

Product Information

Salicylic Acid Wart Remover is a human over the counter drug product labeled by Aso Pharmaceutical Co. Ltd.. The generic name of Salicylic Acid Wart Remover is salicylic acid. The product's dosage form is strip and is administered via topical form.

Product Code51511-596
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.
Salicylic Acid Wart Remover
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 FormStrip - A long narrow piece of material.
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.
Aso Pharmaceutical Co. Ltd.
Labeler Code51511
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.
part358H
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.
02-01-2009
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.
12-31-2023
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 Salicylic Acid Wart Remover?


Product Packages

NDC 51511-596-01

Package Description: 1 POUCH in 1 BOX > 14 STRIP in 1 POUCH

NDC 51511-596-10

Package Description: 1 POUCH in 1 BOX > 10 STRIP in 1 POUCH

NDC 51511-596-12

Package Description: 1200 TRAY in 1 CARTON > 100 POUCH in 1 TRAY > 14 STRIP in 1 POUCH

NDC 51511-596-14

Package Description: 1440 TRAY in 1 CARTON > 120 POUCH in 1 TRAY > 10 STRIP in 1 POUCH

NDC 51511-596-20

Package Description: 2 POUCH in 1 BOX > 10 STRIP in 1 POUCH

Product Details

What are Salicylic Acid Wart Remover 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/1 - A compound obtained from the bark of the white willow and wintergreen leaves. It has bacteriostatic, fungicidal, and keratolytic actions.

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:

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.
  • LANOLIN (UNII: 7EV65EAW6H)
  • NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)

* Please review the disclaimer below.

Patient Education

Salicylic Acid Topical

Salicylic Acid Topical is pronounced as (sal'' i sil' ik as' id)

Why is salicylic acid topical medication prescribed?
Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions ...
[Read More]

* Please review the disclaimer below.

Salicylic Acid Wart Remover Labeling and Warnings

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.

Table of Contents



Active Ingredient



Salicylic acid 40%


Purpose



Wart remover


Uses



  • •for the removal of common warts. The common wart is easily recognized by the rough "cauliflower-like" appearance of the surface

Warnings



For External Use Only


Do Not Use



  • •on irritated skin
  • •on any area that is infected or reddened
  • •on moles
  • •on birthmarks
  • •on warts with hair growing from them
  • •on genital warts
  • •on warts on the face
  • •on warts on mucous membranes such as inside the mouth, nose, anus, genitals, lips

Stop Use And Ask A Doctor If You Have



  • •diabetes
  • •poor blood circulation

Keep Out Of Reach Of Children.



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


Directions



  • •wash affected area
  • •may soak in warm water for 5 minutes
  • •dry area thoroughly
  • •remove medicated pad from backing paper by pulling from center of pad
  • •apply
  • •repeat procedure every 48 hours as needed until wart is removed for up to 12 weeks. If the wart is still present after 12 weeks consult a physician.

Other Information



  • •store at room temperature
  • •avoid excessive heat (37°C, 99°F)

Inactive Ingredients



lanolin, polybutene, rosin ester, rubber


Other



Distributed by:
ASO LLC
Sarasota, FL 34240

*This product is not manufactured or distributed by Medtech Products, Inc.,
owners of the registered trademark, Compound W®.


Principal Display Panel - Carton (Clear)



ONE STEP

WART REMOVER STRIPS

MAXIMUM STRENGTH

SALICYLIC ACID 40%

  • •Comfortable extra cushioning
  • •Waterproof cushion
  • The shape of the pad hides the wart


Principal Display Panel - Carton (Tan)



ONE STEP

WART REMOVER STRIPS

MAXIMUM STRENGTH

SALICYLIC ACID 40%

  • •Comfortable extra cushioning
  • •Waterproof cushion
  • The shape of the pad hides the wart


* Please review the disclaimer below.