NDC 68016-611 Salicylic Acid

Wart Remover

NDC Product Information

Salicylic Acid with NDC 68016-611 is a a human over the counter drug product labeled by Chain Drug Consortium, Llc. The generic name of Salicylic Acid is wart remover. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Chain Drug Consortium, Llc

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.

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 .17 mg/15mL

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.

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

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: Chain Drug Consortium, Llc
Labeler Code: 68016
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: 05-23-2003 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’.

* Please review the disclaimer below.

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

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.

Warnings

For external use only.

Flammable

  • Keep away from fire or flamecap 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 podiatristirritated, infected or reddened skingenital warts and warts on the facemoles, birthmarks and warts with hair growing from themmucous membranes

​When Using This Product

  • Avoid contact with eyes. If product gets into the eyes, flush with water for 15 minutesavoid 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 minutesdry area thoroughlyapply small amount of wart remover with applicator to sufficiently cover each wartlet 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

* Please review the disclaimer below.