Salicylic Acid
Acella Pharmaceuticals, Llc
Human Prescription Drug
NDC 42192-135Salicylic Acid is a human prescription drug labeled by 'Acella Pharmaceuticals, Llc'. National Drug Code (NDC) number for Salicylic Acid is 42192-135. 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: | 42192-135 |
| 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: | Acella 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: | 10 Oct, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 Jan, 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. |
| 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: | Acella 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 |
|---|
| 42192-135-10 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (42192-135-10) / 10 mL in 1 BOTTLE, WITH APPLICATOR | 10 Oct, 2011 | 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 isopropyl alcohol butyl acetate
Indications and Usage:
Indications and uses: salicylic acid, 27.5% wart remover is indicated for the topical treatment and removal of common warts and plantar warts.
Dosage and Administration:
Dosage and administration: prior to application of salicylic acid, 27.5% wart remover, soak wart in warm water for five minutes. remove any loosened tissue by gently rubbing with a brush, wash cloth or emery board. dry thoroughly. using the brush applicator supplied, apply twice to entire wart surface, allowing the first application to dry before applying the second. treatment should be once or twice a day and should continue as directed by physician. be careful not to apply to surrounding skin. clinically visible improvement will normally occur during the first or second week of therapy. maximum resolution may be expected after four to six weeks of use.
Contraindications:
Contraindications: salicylic acid, 27.5% wart remover should not be used by diabetics or patients with impaired blood circulation. salicylic acid, 27.5% wart remover should not be used on moles, birthmarks, unusual warts with hair growing from them or warts on the face.
Adverse Reactions:
Adverse reactions: a localized irritant reaction may occur if salicylic acid, 27.5% wart remover is applied to the normal skin surrounding the wart. any irritation may normally be controlled by temporarily discontinuing use and by applying the medication only to the wart site when treatment is resumed.
Description:
Description: salicylic acid, 27.5% wart remover is a topical preparation containing 27.5% salicylic acid in a film-forming vehicle composed of isopropyl alcohol, isobutyrate, acrylates copolymer, n butyl acetate and polyvinyl butyrate. the pharmacologic activity of salicylic acid, 27.5% wart remover is generally attributed to the keratolytic activity of salicylic acid which is incorporated into a film-forming vehicle designed to cover the wart without the need for a bandage. the structural formula of salicylic acid is: mm1
Clinical Pharmacology:
Clinical pharmacology: although the exact mode of action for salicylic acid in the treatment of warts is not known, 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: salicylic acid, 27.5% wart remover is supplied in 10 ml amber bottles with a brush applicator, (ndc 42192-135-10).
Package Label Principal Display Panel:
Principal display panel - 10 ml ndc 42192-135-10 salicylic acid, 27.5% wart remover film-forming vehicle rx only for dermatological use only. not for use in eyes. 1/3 fl. oz. (10 ml) acella pharmaceuticals, llc. image of carton