NDC 50804-748 Salicylic Acid
Wart Remover Liquid Liquid Topical

Product Information

Product Code50804-748
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
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.
Wart Remover Liquid
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 FormLiquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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.
Geiss Destin & Dunn Inc.
Labeler Code50804
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.
part358B
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.
08-10-2015
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.
12-31-2022
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

Usage Information


Product Packages

NDC 50804-748-03

Package Description: 9 mL in 1 BOTTLE, WITH APPLICATOR

Product Details

Salicylic Acid is a human over the counter drug product labeled by Geiss Destin & Dunn Inc.. The generic name of Salicylic Acid is wart remover liquid. The product's dosage form is liquid and is administered via topical form.


What are Salicylic Acid Active Ingredients?

The following is the list of active ingredients in this product. 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.


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.

  • PYROXYLIN (UNII: KYR8BR2X6O)
  • CAMPHOR (NATURAL) (UNII: N20HL7Q941)
  • CASTOR OIL (UNII: D5340Y2I9G)


* Please review the disclaimer below.

Salicylic Acid 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 17%w/w


Purpose



Wart Remover


Use



for the removal of common and plantar warts. The common wart is easily recognized by the rough 'cauliflower-like' appearance of the surface. The plantar wart exists only on the bottom of the foot and interrupts footprint pattern.


Flammable



keep away from fire or flame
cap bottle tightly and store at room temperature away heat


Do Not Use



if you are a diabetic or have poor blood circulation, except under the advice and supervision of a doctor or podiatrist

irritated, infected or reddened skin

genital warts and warts on the face

moles, birthmarks and warts with hair growing from them

mucous membranes


When Using This Product



avoid contact with eyes. If product gets into the eyes, flush with water for 15 minutes
avoid inhaling vapors


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, may soak wart in warm water for 5 minutes
dry area thoroughly
apply small amount of wart remover with applicator to sufficiently cover each wart
let dry and repeat this procedure once or twice daily until wart is removed for up to 12 weeks


Other Information



store between 20°C to 30°C (68°F to 86°F)


Inactive Ingredients



camphor, castro oil, ethanol, ethyl ether, nitrocellulose


Questions?



Call 1-866-964-0939


Principal Display Panel



GoodSense

Maximum Strength

Liquid Wart Remover

with Salicylic Acid

  • Safely Elminates Common & Plantar Warts
  • Convenient Applicator Brush
  • Safe & Effective
  • NET WT 0.31 FL OZ (9 mL)



* Please review the disclaimer below.