Salicylic Acid
Acella Pharmaceuticals, Llc
Human Prescription Drug
NDC 42192-130Salicylic Acid is a human prescription drug labeled by 'Acella Pharmaceuticals, Llc'. National Drug Code (NDC) number for Salicylic Acid is 42192-130. This drug is available in dosage form of Aerosol, Foam. The names of the active, medicinal ingredients in Salicylic Acid drug includes Salicylic Acid - 6 g/100g . The currest status of Salicylic Acid drug is Active.
Drug Information:
| Drug NDC: | 42192-130 |
| 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: | Aerosol, Foam |
| 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 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: | 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: | 17 May, 2011 |
| 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: | Acella Pharmaceuticals, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 790884
|
| 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 |
|---|
| 42192-130-02 | 200 g in 1 CANISTER (42192-130-02) | 17 May, 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 dimethicone ethylparaben glycerin methylcellulose (100 cps) methylparaben phenoxyethanol polyoxyl 40 stearate polysorbate 20 polysorbate 80 povidone propylene glycol propylparaben water sodium citrate sodium hydroxide stearic acid trolamine butane propane salicylic acid salicylic acid
Drug Interactions:
Drug interactions. (the following interactions are from a published review and include reports concerning both oral and topical salicylate administration. the relationship of these interactions to the use of salicylic acid 6% foam is not known.) i. due to the competition of salicylate with other drugs for binding to serum albumin the following drug interactions may occur: drug description of interaction tolbutamide; sulfonylureas hypoglycemia potentiated methotrexate decrease tubular reabsorption; clinical toxicity from methotrexate can result oral anticoagulants increased bleeding ii. drugs changing salicylate levels by altering renal tubular reabsorption: drug description corticosteroids decreases plasma salicylate level; tapering doses of steroids may promote salicylism ammonium sulfate increases plasma salicylate level iii. drugs with complicated interactions with salicylates: drug description heparin salicylate decreases platelet adhesivesness and interferes with hemostasis in hep
Read more...arin-treated patients pyrazinamide inhibits pyrazinamide-induced hyperuricemia uricosuric agents effect of probenecid, sulfinpyrazone and phenylbutazone inhibited
Indications and Usage:
Indications and usage for dermatologic use: salicylic acid 6% foam is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders, including verrucae and the various ichthyoses, keratosis palmaris and plantaris, keratosis pilaris, pityriasis rubra pilaris and psoriasis. for podiatric use: salicylic acid 6% foam is a topical aid in the removal of excessive keratin on dorsal and plantar hyperkeratotic lesions.
Warnings:
Warnings salicylic acid 6% foam is for external use only. it is not for ophthalmic, oral, anal or intravaginal use. contact with eyes, lips, broken or inflamed skin, and all mucous membranes should be avoided. salicylic acid 6% foam should not be used by persons who have a known hypersensitivity to salicylic acid or any of the other listed ingredients. prolonged use over large areas, especially in children and those patients with significant renal or hepatic impairment could result in salicylism. 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, hyperpnoea, diarrhea, psychic disturbances. in the event of salicylic acid toxicity,
Read more...the use of salicylic acid 6% foam should be discontinued. fluids should be administered to promote urinary excretion. treatment with sodium bicarbonate (oral or intravenous) should be instituted as appropriate. considering the potential of developing reyeâs syndrome, salicylate products should not be administered to children or teenagers with varicella or influenza, unless directed by a physician.
General Precautions:
Keep this and all other medications out of the reach of children.
Dosage and Administration:
Dosage and administration unless otherwise directed by a prescribing physician, salicylic acid 6% foam should be applied to the affected area twice a day. salicylic acid 6% foam should be rubbed into the skin until it is completely absorbed. salicylic acid 6% foam should be shaken vigorously before each application and inverted to administer.
Dosage Forms and Strength:
Dosage - see warnings
Contraindications:
Contraindications salicylic acid 6% foam should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. salicylic acid 6% foam should not be used in children under 2 years of age.
Adverse Reactions:
Adverse reactions transient stinging, burning, itching or irritation is possible. peeling of the skin may increase as the salicylic acid works to loosen excess keratin. if excessive burning, stinging or peeling occurs, discontinue use and consult your physician.
Drug Interactions:
Drug interactions. (the following interactions are from a published review and include reports concerning both oral and topical salicylate administration. the relationship of these interactions to the use of salicylic acid 6% foam is not known.) i. due to the competition of salicylate with other drugs for binding to serum albumin the following drug interactions may occur: drug description of interaction tolbutamide; sulfonylureas hypoglycemia potentiated methotrexate decrease tubular reabsorption; clinical toxicity from methotrexate can result oral anticoagulants increased bleeding ii. drugs changing salicylate levels by altering renal tubular reabsorption: drug description corticosteroids decreases plasma salicylate level; tapering doses of steroids may promote salicylism ammonium sulfate increases plasma salicylate level iii. drugs with complicated interactions with salicylates: drug description heparin salicylate decreases platelet adhesivesness and interferes with hemostasis in hep
Read more...arin-treated patients pyrazinamide inhibits pyrazinamide-induced hyperuricemia uricosuric agents effect of probenecid, sulfinpyrazone and phenylbutazone inhibited
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 in the human. there are no adequate and well-controlled studies in pregnant women. salicylic acid 6% foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Description:
Description salicylic acid 6% foam is applied topically and used in the removal of excessive keratin in hyperkeratotic skin disorders. each gram of salicylic acid 6% foam contains salicylic acid 6% as the active ingredient, and the following inactive ingredients: dimethicone, ethylparaben, glycerin, methylcellulose, methylparaben, phenoxyethanol, polyoxyl 40 stearate, polysorbate 20, polysorbate 80, povidone, propylene glycol, propylparaben, purified water, sodium citrate, sodium hydroxide, stearic acid and trolamine and in propellants butane and propane.
Clinical Pharmacology:
Clinical pharmacology salicylic acid has been shown to produce desquamation of the horny layer of skin while not affecting qualitative or quantitative changes in structure of the viable epidermis. the mechanism of action has been attributed to dissolution of intercellular cement substance. in a study of the percutaneous absorption of salicylic acid from salicylic acid 6% foam in four patients with extensive active psoriasis, taylor and halprin showed that peak serum 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/100ml). peak serum levels occurred within 5 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 extracellular space, patients with a contracted extracellular space due to dehydration or diuretics have higher salic
Read more...ylate levels than those with a normal extracellular 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 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 salicylate is protein bound to albumin. salicylates compete with the binding of several drugs and can modify the action of these drugs. by similar competetive mechanisms other drugs can influence the serum levels of salicylate. (see precautions ).
Pharmacokinetics:
Pharmacokinetics the mechanism of action of topically applied salicylic acid has been attributed to the dissolution of intercellular cement substance.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility - no data are available concerning potential carcinogenic or reproductive effects of salicylic acid 6% foam. it has been shown to lack mutagenic potential in the ames salmonella test.
How Supplied:
How supplied salicylic acid 6% foam is supplied in a 70 gram or 2.5 ounce aerosolized canister bearing the ndc number 42192-112-70 and a 200 gram or 7.1 ounce aerolized canister bearing the ndc number 42192-130-02 .
Package Label Principal Display Panel:
"package label.principal display panel - 200 g ndc 42192-130-02 salicylic acid 6% foam hydrating topical foam rx only net wt. 7.1 oz. (200 g) acella pharmaceuticals llc container-200 g