NDC 68927-3792 Pediquick Onestep Wart Removers

Salicylic Acid

NDC Product Code 68927-3792

NDC Code: 68927-3792

Proprietary Name: Pediquick Onestep Wart Removers 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.

Non-Proprietary Name: Salicylic Acid 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.

NDC Code Structure

  • 68927 - Pedifix, Inc,
    • 68927-3792 - Pediquick Onestep Wart Removers

NDC 68927-3792-1

Package Description: 1 CELLO PACK in 1 BLISTER PACK > 14 PLASTER in 1 CELLO PACK

NDC Product Information

Pediquick Onestep Wart Removers with NDC 68927-3792 is a a human over the counter drug product labeled by Pedifix, Inc,. The generic name of Pediquick Onestep Wart Removers is salicylic acid. The product's dosage form is plaster and is administered via topical form.

Labeler Name: Pedifix, Inc,

Dosage Form: Plaster - Substance intended for external application made of such materials and of such consistency as to adhere to the skin and attach to a dressing; plasters are intended to afford protection and support and/or to furnish an occlusion and macerating action and to bring medication into close contact with the skin.

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.

Pediquick Onestep Wart Removers 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 11.04 mg/1

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.

  • ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • BROWN IRON OXIDE (UNII: 1N032N7MFO)

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: Pedifix, Inc,
Labeler Code: 68927
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: 05-01-2019 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.

Pediquick Onestep Wart Removers Product Label Images

Pediquick Onestep Wart Removers 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%

Purpose

Wart remover

Uses

For the removal of common warts. The common wart is easily recognized by the rough ‘cauliflower-like’ appearance on the surface

Warnings

For external use only

Do Not Use This Product

  • On irritated skinon any area that is infected or reddenedif you are diabetciif you have poor blood circulation

If Discomfort Persists,

See your doctor or podiatrist.

Do Nou Use On

  • Molesbirthmarkswarts with hair growing from themgenital wartsor warts on the face or mucus membranes.

Keep Out Of Reach Of Children.

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

Directions

  • Wash affected areamay soak in warm water for 5 minutesdry area thoroughlyremove bandage from backingapply medicated strip, positioning medicated area directly over wartrepeat procedure every 48 hours as needed (until wart is removed) fo up to 12 weeks

Other Information

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

Inactive Ingredients

Polyvinyl Alcohol, Acrylic Copolymer

* Please review the disclaimer below.

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