Salicylic Acid
Kmm Pharmaceuticals, Llc
Human Prescription Drug
NDC 52187-527Salicylic Acid is a human prescription drug labeled by 'Kmm Pharmaceuticals, Llc'. National Drug Code (NDC) number for Salicylic Acid is 52187-527. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Salicylic Acid drug includes Salicylic Acid - 275 mg/mL . The currest status of Salicylic Acid drug is Active.
Drug Information:
| Drug NDC: | 52187-527 |
| 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 Prescription 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: | Kmm Pharmaceuticals, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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 - 275 mg/mL
|
| 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: | UNAPPROVED DRUG OTHER |
| 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: | 14 Nov, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 Dec, 2025 |
| 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. |
| 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: | KMM Pharmaceuticals, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1095689
|
| 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. |
| 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 |
|---|
| 52187-527-10 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (52187-527-10) / 10 mL in 1 BOTTLE, WITH APPLICATOR | 14 Nov, 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. |
Product Elements:
Salicylic acid salicylic acid salicylic acid salicylic acid
Indications and Usage:
Indications and usage: this product is indicated for the topical treatment and removal of common warts and plantar warts.
Warnings:
Warnings: keep out of reach of children. this product is flammable. keep away from fire or flame. keep bottle tightly closed when not in use.
Dosage and Administration:
Dosage and administration: prior to applying this product, soak wart in warm water for five minutes. remove any loose tissue by gently rubbing with a wash cloth, emery board, or pumice stone. dry the wart site thoroughly. using the brush applicator supplied, apply this product twice to the entire wart surface, allowing the first application to dry before applying the second. continue treatment once or twice a day or as directed by a physician. be careful not to apply to surrounding skin. clinically visible improvement normally occurs during the first or second week of therapy. resolution may be expected after four to six weeks of this productâs use, though some warts may take longer to remove.
Contraindications:
Contraindications: this product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. patients with diabetes or impaired blood circulation should not use this product. this product also should not be used on moles, birthmarks, and unusual warts with hair growing from them, or warts on the face.
Adverse Reactions:
Adverse reactions: localized irritation may occur if this product is applied to normal skin surrounding the wart; however irritation may normally be controlled by temporarily discontinuing use and by applying the medication only to the wart site when treatment is resumed. to report a serious adverse event, call 1-855-899-4237.
Description:
Description: each ml contains 275 mg of salicylic acid in a film-forming vehicle consisting of acrylates copolymer, isopropyl alcohol, n-butyl acetate, polyvinyl butyral, and trimethyl pentanyl diisobutyrate. the pharmacologic activity of this product is generally attributed to the keratolytic activity of salicylic acid, which is incorporated into a polyacrylic, film-forming vehicle designed to cover the wart without the need for a bandage. the structural formula of salicylic acid is: structure.jpg
Clinical Pharmacology:
Clinical pharmacology: although the exact mode of action for salicylic acid in the treatment of warts is unknown, its activity appears to be associated with its keratolytic action, which results in mechanical removal of epidermal cells infected with wart viruses.
How Supplied:
How supplied: 1/3 fl. oz. (10 ml) bottles, ndc 52187-527-10 store at 20°c to 25°c (68°f to 77°f), excursions permitted between 15°c to 30°c (between 59°f to 86°f). brief exposure to temperatures up to 40°c (104°f) may be tolerated provided the mean kinetic temperature does not exceed 25°c (77°f); however, such exposure should be minimized. protect from freezing and excessive heat. keep bottle tightly closed. manufactured for: kmm pharmaceuticals, llc 1000 n. west street suite 1200, #1021 wilmington, de 19801 v1 rev. 10/2017 827633
Package Label Principal Display Panel:
Carton.jpg