Vircin Advanced Wart Treatment
Salicylic Acid
Pure Source, Llc
Human Otc Drug
NDC 65121-397Vircin Advanced Wart Treatment also known as Salicylic Acid is a human otc drug labeled by 'Pure Source, Llc'. National Drug Code (NDC) number for Vircin Advanced Wart Treatment is 65121-397. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Vircin Advanced Wart Treatment drug includes Salicylic Acid - 17 g/100g . The currest status of Vircin Advanced Wart Treatment drug is Active.
Drug Information:
| Drug NDC: | 65121-397 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Vircin Advanced Wart Treatment |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Salicylic Acid |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Pure Source, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | SALICYLIC ACID - 17 g/100g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 12 Jun, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part358B |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Pure Source, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | O414PZ4LPZ
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 65121-397-15 | 1 TUBE in 1 CARTON (65121-397-15) / 14 g in 1 TUBE | 10 Feb, 2017 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose wart remover
Product Elements:
Vircin advanced wart treatment salicylic acid butylated hydroxytoluene ethyl pyruvate glycerin povidone-iodine propylene glycol trolamine salicylic acid salicylic acid
Indications and Usage:
Uses: for the removal of plantar warts on the bottom of the foot. the plantar wart is recognized by its location only on the bottom of the foot, its tenderness and the interruption of the footprint pattern. for the removal of common warts. the common wart is easily recognized by the rough âcauliflower-likeâ appearance of the surface.
Warnings:
Warnings for external use only. do not use on irritated skin, infected or reddened areas, moles, birthmarks, warts with hair growing from them, genital warts, warts on the face or mucous membrane. ask a doctor before use if you have diabetes or poor blood circulation. 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. flammable. keep away from fire and flame. cap tube 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 right away.
Dosage and Administration:
Directions: wash affected area, may soak in warm water for 5 minutes. dry area thoroughly. by squeezing tube gently, apply one drop at a time to sufficiently cover each wart. let dry. repeat this procedure twice daily as needed (until wart is removed) for up to 12 weeks or as directed by a doctor.
Package Label Principal Display Panel:
Vircin advanced wart treatment 0.5oz/14g (65121-397-15) vircintube vircinbox