Salicylic Acid
Wart Remover Gel Pen
Harmon Store Inc.
Human Otc Drug
NDC 63940-023Salicylic Acid also known as Wart Remover Gel Pen is a human otc drug labeled by 'Harmon Store Inc.'. National Drug Code (NDC) number for Salicylic Acid is 63940-023. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Salicylic Acid drug includes Salicylic Acid - .17 g/g . The currest status of Salicylic Acid drug is Active.
Drug Information:
| Drug NDC: | 63940-023 |
| 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: | Salicylic Acid |
| 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: | Wart Remover Gel Pen |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Harmon Store Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| 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/g
|
| 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: | 01 Sep, 2015 |
| 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, 2024 |
| 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: | Harmon Store Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 312880
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0070922104254
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 63940-023-04 | 1.25 g in 1 APPLICATOR (63940-023-04) | 01 Sep, 2015 | 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:
âpurpose wart remover
Product Elements:
Salicylic acid wart remover gel pen camphor (natural) alcohol ethyl acetate hypophosphorous acid hydroxypropyl cellulose (1600000 wamw) polysorbate 80 pyroxylin salicylic acid salicylic acid
Indications and Usage:
âuse for the removal of common and plantar warts. the common wart is easily recognized by the rough 'cauliflower-like' appearance of the surface plantar wart is recognized by its location only on the bottom of the foot, its tenderness and the interruption of the footprint pattern
Warnings:
âwarnings âfor external use only. âflammable keep away from fire or flame do not use if you are a diabetic or have poor blood circulation, except under the advice and supervision of a doctor or podiatrist on moles, birthmarks and warts with hair growing from them on mucous membranes on irritated, infected or reddened skin on genital warts and warts on the face when using this product avoid contact with eyes if product gets into the eyes, flush with water for 15 minutes avoid inhaling vapors stop use and consult a doctor if discomfort persists keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Do Not Use:
âwarnings âfor external use only. âflammable keep away from fire or flame do not use if you are a diabetic or have poor blood circulation, except under the advice and supervision of a doctor or podiatrist on moles, birthmarks and warts with hair growing from them on mucous membranes on irritated, infected or reddened skin on genital warts and warts on the face when using this product avoid contact with eyes if product gets into the eyes, flush with water for 15 minutes avoid inhaling vapors stop use and consult a doctor if discomfort persists keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product avoid contact with eyes if product gets into the eyes, flush with water for 15 minutes avoid inhaling vapors
Dosage and Administration:
Directions wash affected area may soak wart in for 5 minutes dry area thoroughly remove cap from pen remove insert pin from the tip twist and click pen until wart remover gel is dispense onto the tip of the applicator. initial use will require several rotations for the gel to load apply a small amount at a time with applicator 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 for storage ensure applicator is free of excess gel before placing the insert pin back into the tip
Stop Use:
Stop use and consult a doctor if discomfort persists
Package Label Principal Display Panel:
Principal display panel harmon face values maximum strength wart remover gel pen salicylic acid safely removes common and plantar warts no-drip gel 1 prefilled pen net wt 0.04 oz (1.25 g) wart remover pen
Further Questions:
Questions? â call 1-866-964-0939