NDC 44577-020 Verrustat Wart Remover

Salicylic Acid

NDC Product Information

Verrustat Wart Remover with NDC 44577-020 is a a human over the counter drug product labeled by Clinical Therapeutic Solutions. The generic name of Verrustat Wart Remover is salicylic acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Clinical Therapeutic Solutions

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug 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.

Verrustat Wart Remover Active Ingredient(s)

What 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 170 mg/mL

Inactive Ingredient(s)

About 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.

  • BUTYL ACETATE (UNII: 464P5N1905)
  • ETHYL ACETATE (UNII: 76845O8NMZ)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • PYROXYLIN (UNII: KYR8BR2X6O)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • ALCOHOL (UNII: 3K9958V90M)

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.
  • 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.

Labeler Name: Clinical Therapeutic Solutions
Labeler Code: 44577
FDA Application Number: part358B 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.

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

Start Marketing Date: 10-16-2013 What 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 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

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.

Verrustat Wart Remover Product Label Images

Verrustat Wart Remover 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 17%

Purpose

Wart treatment

Uses:

  • For the removal of common and plantar warts. The common wart has a rough 'cauliflower-like' appearance. The plantar wart exists only on the bottom of the foot  and interrupts the footprint pattern.

Warnings

For external use only. Do not use this product on irritated skin, on any area that is infected or reddened, if you are a diabetic, or if you have poor blood circulation. If discomfort persists, see your doctor. Do not use on moles, birthmarks, warts with hair growing from them, genital warts, or warts on the face or mucous membranes. Flammable. Keep away from fire or flame. Cap bottle tightly and store at room temperature away from heat. If product gets into the eye, flush with water for 15 minutes. Avoid inhaling vapors.

Directions

  • Wash or soak the affected area and dry thoroughlyapply wart remover liquid, with enclosed applicatorreapply subsequent applications over existing applicationrepeat the procedure once or twice daily, until wart is completely removed, for up to 12 weeks

Other Information

  • Store between 20 degrees to 30 degrees C (68 degrees to 86 degrees F)

Other Ingredients

Butyl Acetate, Ethyl Acetate, Isopropyl Alcohol, Methylsulfonylmethane (MSM), Nitrocellulose, Retinyl Palmitate, SD-Alcohol 40B

* Please review the disclaimer below.