NDC 36800-005 Salicylic Acid

Liquid Corn And Callus Remover

NDC Product Information

Salicylic Acid with NDC 36800-005 is a a human over the counter drug product labeled by Topco Associates Llc. The generic name of Salicylic Acid is liquid corn and callus remover. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Topco Associates 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/9.8mL

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: Topco Associates Llc
Labeler Code: 36800
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: 01-03-2012 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 17%w/w

Purpose

Corn and callus remover

Uses

  • For the removal of corns and callusesrelieves pain by removing corns and calluses

Warnings

​For external use only.

Flammable

  • Keep away from fire or flamecap bottle tightly and store at room temperature away heat

Do Not Use

  • On irritated skinon any area that is infected or reddenedif you are a diabetic, or if you have poor blood circulation, except under the advice and supervision of a doctor or podiatrist

When Using This Product

  • Avoid contact with eyesavoid inhaling vaporsif product gets into the eyes, flush with water for 15 minutes

Stop And Ask A Doctor If

Discomfort persists, see your doctor or podiatrist

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Wash affected area and dry thoroughlyapply one drop at a time with applicator, to sufficiently cover each corn/callus; let dryuse cushions with hole centered over corn or callus to relieve pressure (additional cushions may be purchased separately)repeat this procedure once or twice daily as needed for up to 14 days (until corn/callus is removed)

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 1-888-423-0139

* Please review the disclaimer below.