NDC 63029-597 Compound W Liquid - First Aid

Salicylic Acid

NDC Product Code 63029-597

NDC 63029-597-24

Package Description: 1 BOTTLE, WITH APPLICATOR in 1 CARTON > 9 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Compound W Liquid - First Aid with NDC 63029-597 is a a human over the counter drug product labeled by Medtech Products Inc.. The generic name of Compound W Liquid - First Aid is salicylic acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Medtech Products Inc.

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.

Compound W Liquid - First Aid 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 150 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.

  • ALCOHOL (UNII: 3K9958V90M)
  • CAMPHOR (NATURAL) (UNII: N20HL7Q941)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • LYTTA VESICATORIA (UNII: 3Q034RO3BT)
  • ETHER (UNII: 0F5N573A2Y)
  • ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
  • HYPOPHOSPHOROUS ACID (UNII: 8B1RL9B4ZJ)
  • MENTHOL (UNII: L7T10EIP3A)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)

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: Medtech Products Inc.
Labeler Code: 63029
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: 03-01-2014 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 - NO 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".

* Please review the disclaimer below.

Compound W Liquid - First Aid 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

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 is recognized by its location only on the bottom of the foot, its tenderness and the interruption of the footprint pattern.

Warnings

For external use only

Do Not Use


     
on irritated skin or on any area that is infected or reddened. •
     
on moles, birthmarks, warts with hair growing from them, genital warts or warts on the face or mucous membranes. •
     
if you have diabetes or poor blood circulation.

When Using This Product


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

Stop Use And Ask A Doctor If Discomfort Persists

Extremely flammable. Keep away from fire and flame. Cap bottle tightly and store at room temperature away from heat.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions


     
wash affected area•
     
may soak wart in warm water for 5 minutes •
     
dry area thoroughly •
     
using applicator, apply one drop at a time to sufficiently cover each wart •
     
let dry •
     
repeat this procedure once or twice daily as needed (until wart is removed) for up to 12 weeks

Inactive Ingredients

Alcohol, camphor, castor oil, collodion, ether , ethylcellulose, hypophosphorous acid, menthol, polysorbate 80

Questions?

1-800-443-4908 CompoundW.com

* Please review the disclaimer below.