NDC 69842-294 Salicylic Acid

Hydrogel Clear Wart Remover

NDC Product Information

Salicylic Acid with NDC 69842-294 is a a human over the counter drug product labeled by Cvs Pharmacy. The generic name of Salicylic Acid is hydrogel clear wart remover. The product's dosage form is patch and is administered via topical form.

Labeler Name: Cvs Pharmacy

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 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 40 mg/121

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.

  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • VINYL ACETATE (UNII: L9MK238N77)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)

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: Cvs Pharmacy
Labeler Code: 69842
FDA Application Number: part358F 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: 02-01-2020 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’.

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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

Wart remover

Use

  • 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

  • If you are a diabeticif you have poor blood circulationon irritated, infected or reddened skinon genital warts and warts on the faceon moles, birthmarks and warts with hair growing from themon mucous membranes

Stop Use And Ask A 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 minutesdry area thoroughlyif necessary, cut medicated disc to fit wartapply adhesive side down of disc onto wartcover disc with cushions to conceal arearepeat this procedure every 48 hours as needed (until wart is removed) for up to 12 weeks

Other Information

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

Inactive Ingredients

Acrylic adhesive, acrylic polymer, polyethylene, polyvinyl alcohol

Questions?

Call 1-866-964-0939

* Please review the disclaimer below.