NDC 56104-240 Salicylic Acid

Wart Remover Gel Pen

NDC Product Information

Salicylic Acid with NDC 56104-240 is a a human over the counter drug product labeled by Premier Brands Of America, Inc.. The generic name of Salicylic Acid is wart remover gel pen. The product's dosage form is gel and is administered via topical form.

Labeler Name: Premier Brands Of America, Inc.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Salicylic Acid 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 .21 g/1.25g

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.

  • 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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Premier Brands Of America, Inc.
Labeler Code: 56104
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: 01-01-2021 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: 12-31-2021 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’.

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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 17%w/w


Wart remover


  • For the removal of common and plantar warts. The common wart is easily recognized by the rough 'cauliflower-like' appearance of the surfacethe plantar wart is recognized by its location only on the bottom of the foot, its tenderness and the interruption of the footprint pattern


For external use only.


  • Keep away from fire or flame

​Do Not Use

  • If you are a diabetic or have poor blood circulation, except under the advice and supervision of a doctor or podiatriston moles, birthmarks and warts with hair growing from themon mucous membranes on irritated, infected or reddened skinon genital warts and warts on the face

​Ask Doctor Before Use If You Have:

  • Diabetespoor blood circulation

​When Using This Product

  • Avoid contact with eyesif product gets into the eyes, flush with water for 15 minutesavoid inhaling vapors

​Stop Use And Consult A Doctor If

Discomfort persists

​Keep Out Of Reach Of Children.

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


  • Wash affected areamay soak wart in for 5 minutesdry area thoroughlyremove cap from pentwist and click pen until wart remover gel is dispense onto the tip of the applicator. Initial use will require several rotations for the gel to loadapply a small amount at a time with applicator to sufficiently cover each wartlet dryrepeat this procedure once or twice daily as needed (until wart is removed) for up to 12 weeksfor storage ensure applicator is free of excess gel before placing the insert pin back into the tip

Other Information

  • Store between 59°F to 86°F (15°C to 30°C)if gel hardens at tip of applicator, dispense product and remove blockage

​Inactive Ingredients

Camphor, castro oil, ethyl acetate, hydroxypropyl cellulose, hypophosphorous acid, isopropyl alcohol, nitrocellulose, polysorbate 80, SDA 3C ethyl alcohol


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