Salicylic Acid 6 Percent
Salicylic Acid
Prugen Llc
Human Prescription Drug
NDC 42546-279Salicylic Acid 6 Percent also known as Salicylic Acid is a human prescription drug labeled by 'Prugen Llc'. National Drug Code (NDC) number for Salicylic Acid 6 Percent is 42546-279. This drug is available in dosage form of Shampoo. The names of the active, medicinal ingredients in Salicylic Acid 6 Percent drug includes Salicylic Acid - 6 mg/100mL . The currest status of Salicylic Acid 6 Percent drug is Active.
Drug Information:
| Drug NDC: | 42546-279 |
| 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 6 Percent |
| 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: | Prugen Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Shampoo |
| 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 - 6 mg/100mL
|
| 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: | 01 Jan, 2009 |
| 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: | PruGen LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 667904
|
| 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 |
|---|
| 42546-279-06 | 1 BOTTLE in 1 BOX (42546-279-06) / 177 mL in 1 BOTTLE | 01 Jan, 2009 | 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 6 percent salicylic acid salicylic acid salicylic acid water carbomer copolymer type a (allyl pentaerythritol crosslinked) sodium laureth-3 sulfate trolamine quaternium-22 cocamidopropyl betaine behentrimonium methosulfate propylparaben methylparaben glycerin edetate disodium chamomile
Indications and Usage:
Indications and usage for dermatologic use salicylic acid 6% (w/w) shampoo is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders, including verrucae, and the various ichthyoses (vulgaris, sex-linked and lamellar), keratosis palmaris and plantaris, keratosis pilaris, pityriasis rubra pilaris, and psoriasis (including body, scalp, palms and soles). for podiatric use salicylic acid 6% (w/w) shampoo is a topical aid in the removal of excessive keratin on the dorsal and plantar hyperkeratotic lesions. topical preparations of 6% salicylic acid have been reported to be useful adjunctive therapy for verrucae plantares.
Warnings:
Warnings prolonged use over large areas, especially in children and those patients with significant renal or hepatic impairment could resultin salicylism. excessive application of the product other than is needed to cover the affected area will not result in more therapeutic benefit. concomitant use of other drugs which may contribute to elevated serum salicylate levels should be avoided where the potential for toxicity is present. in children under 12 years of age and those patients with renal or hepatic impairment, the area to be treated should be limited and the patient monitored closely for signs of salicylate toxicity: nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnea, diarrhea, and psychic disturbances. in the event of salicylic acid toxicity, the use of the salicylic acid 6% (w/w) shampoo should be discontinued. fluids should be administered to promote urinary excretion. treatment with sodium bicarbonate (oral or intravenous) should be instituted as app
Read more...ropriate. patients should be cautioned against the use of oral aspirin and other salicylate containing medications, such as sports and injury creams, to avoid additional excessive exposure to salicylic acid. where needed, aspirin should be replaced by an alternative non-steroidal, anti-inflammatory agent that is not salicylate based. due to potential risk of developing reye's syndrome, salicylate products should not be used in children and teenagers with varicella or influenza, unless directed by a physician.
Dosage and Administration:
Dosage and administration wet hair and apply salicylic acid 6% (w/w) shampoo to the scalp. work into a lather then rinse. repeat the treatment as needed until the condition clears. once clearing is apparent, the occasional use of salicylic acid 6% (w/w) shampoo will usually maintain the remission.
Contraindications:
Contraindications salicylic acid 6% (w/w) shampoo should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. salicylic acid 6% (w/w) shampoo should not be used in children under 2 years of age.
Adverse Reactions:
Adverse reactions excessive erythema and scaling conceivably could result from use on open skin lesions.
Use in Pregnancy:
Pregnancy (category c) salicylic acid has been shown to be teratogenic in rats and monkeys. it is difficult to extrapolate from oral doses of acetylsalicylic acid used in these studies to topical administration as the oral dose to monkeys may represent six times the maximal daily human dose of salicylic acid when applied topically over a large body surface. there are no adequate and well-controlled studies in pregnant women. salicylic acid 6% (w/w) shampoo should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Overdosage:
Overdosage see warnings .
Description:
Description shampoo contains 6% w/w salicylic acid usp in a vehicle composed of purified water, disodium laureth sulfosuccinate, cocamidopropyl betaine, hexylene glycol, linoleamidpropyl pg-dimonium chloride phosphate, polyquaternium-22, propylene glycol, sodium c14-16 olefin sulfonate, sodium citrate, sodium lauryl sarcosinate, tetrasodium edta, tocopherol acetate and fragrance. salicylic acid is the 2-hydroxy derivative of benzoic acid having the following structure: chemical structure
Clinical Pharmacology:
Clinical pharmacology salicylic acid has been shown to produce desquamation of the horny layer of skin while not effecting qualitative or quantitative changes in the structure of the viable epidermis. the mechanism of action has been attributed to a dissolution of inter cellular cement substance. in a study of the percutaneous absorption of salicylic acid in a 6%salicylic acid gel in four patients with extensive active psoriasis, taylor and halprin showed that the peak serum salicylate levels never exceeded 5 mg/100 ml even though more than 60% of the applied salicylic acid was absorbed. systemic toxic reactions are usually associated with much higher serum levels (30 to 40 mg/100 ml). peak serum levels occurred within five hours of the topical application under occlusion. the sites were occluded for 10 hours over the entire body surface below the neck. since salicylates are distributed in the extra cellular space, patients with a contracted extra cellular space due to dehydration or d
Read more...iuretics have a higher salicylate levels than those with a normal extra cellular space. (see precautions ) the major metabolites identified in the urine after topical administration are salicyluric acid (52%), salicylate glucuronides (42%) and free salicylic acid (6%). the urinary metabolites after percutaneous absorption differ from those after oral salicylate administration; those derived from percutaneous absorption contain more salicylate glucuronides and less salicyluric and salicylic acid. almost 95% of a single dose of salicylate is excreted within 24 hours of its entrance into the extracellular space. fifty to eighty percent of a salicylate is protein bound to albumin. salicylates compete with the binding of several drugs and can modify the actions of these drugs; by similar competitive mechanisms other drugs can influence the serum levels of salicylate.(see precautions )
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility no data is available concerning potential carcinogenic or reproductive effects of salicylic acid 6% (w/w) shampoo. salicylic acid has been shown to lack mutagenic potential in the ames salmonella test.
How Supplied:
How supplied salicylic acid 6% (w/w) shampoo is available in 177ml plastic bottles (ndc 42546-279-06). store at controlled room temperature 20°-25°c (68°-77°f). do not freeze.
Package Label Principal Display Panel:
Principal display panel - 177 ml bottle box ndc 42546-279-06 salicylic acid 6% (w/w) shampoo rx only for dermatological use only not for ophthalmic, oral or intravaginal use 177 ml prugen ® pharmaceuticals principal display panel - 177 ml bottle box