Keralyt
Salicylic Acid
Summers Laboratories Inc
Human Prescription Drug
NDC 11086-030Keralyt also known as Salicylic Acid is a human prescription drug labeled by 'Summers Laboratories Inc'. National Drug Code (NDC) number for Keralyt is 11086-030. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Keralyt drug includes Salicylic Acid - 6 g/100g . The currest status of Keralyt drug is Active.
Drug Information:
| Drug NDC: | 11086-030 |
| 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: | Keralyt |
| 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: | Summers Laboratories 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 - 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: | 01 Nov, 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, 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: | Summers Laboratories Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 212332
312893
|
| 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 |
|---|
| 11086-030-10 | 100 g in 1 TUBE (11086-030-10) | 01 Nov, 2009 | N/A | No |
| 11086-030-40 | 40 g in 1 TUBE (11086-030-40) | 01 Nov, 2009 | N/A | No |
| 11086-030-60 | 60 g in 1 BOTTLE, WITH APPLICATOR (11086-030-60) | 01 Nov, 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:
Keralyt salicylic acid propylene glycol alcohol hydroxypropyl cellulose water salicylic acid salicylic acid
Drug Interactions:
Drug interactions. (the following interactions are from a published review âµ and include reports concerning both oral and topical salicylate administration. the relationship of these interactions to the use of keralyt gel 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 decreases tubular reabsorption; clinical toxicity from methotrexate can result oral anticoagulant 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 adhesiveness and interferes with hemostasis in heparin-
Read more...treated patients pyrazinamide inhibits pyrazinamide-induced hyperuricemia uricosuric agents effect of probenecid, sulfinpyrazone and phenylbutazone inhibited the following alterations of laboratory tests have been reported during salicylate therapy ⶠ: laboratory tests effect of salicylates thyroid function decreased pbi; increased t 3 uptake urinary sugar false negative with glucose oxidase; false positive with clinitest with high-dose salicylate therapy (2-5 g qd) 5 hydroxyindole acetic acid false negative with fluorometric test acetone, ketone bodies false positive fecl 3 in gerhardt reaction; red color persists with boiling 17-oh corticosteroids false reduced values with >4.8 g qd salicylate vanilmandelic acid false reduced values uric acid may increase or decrease depending on dose prothrombin decreased levels; slightly increased prothrombin time
Indications and Usage:
Indications and usage - for the removal of excess keratin in hyperkeratotic disorders, including scaling associated with scalp psoriasis or thickened skin of palms and soles, corns and calluses.
Warnings:
Warnings: 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, the use of keralyt gel 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 risk of developing reyeâs syndrome, salicylate products should not be administered to children or teenagers with
Read more...varicella or influenza, unless directed by a physician.
Dosage and Administration:
Dosage and administration - the preferable method of use is to apply keralyt gel thoroughly to the affected area and occlude the area at night. preferably, the skin should be hydrated for at least five minutes prior to application. the medication is washed off in the morning and if excessive drying and/or irritation is observed a bland cream or lotion may be applied. once clearing is apparent, the occasional use of keralyt gel will usually maintain the remission. in those areas where occlusion is difficult or impossible, application may be made more frequently; hydration by wet packs or baths prior to application apparently enhances the effect. unless hands are being treated, hands should be rinsed thoroughly after application. for use as a scalp treatment: keralyt gel should be applied directly to the affected areas of the scalp on a frequency directed by your physician. the applicator tip will provide accurate application, avoiding contact with normal hair or skin. the gel should be
Read more...washed off after 10 to 20 minutes initially, but it can be left on for up to an hour as treatment progresses. the gel can be washed off using keralyt shampoo or warm water in a bath or shower.
Contraindications:
Contraindications: keralyt gel should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredient. keralyt 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.
Drug Interactions:
Drug interactions. (the following interactions are from a published review âµ and include reports concerning both oral and topical salicylate administration. the relationship of these interactions to the use of keralyt gel 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 decreases tubular reabsorption; clinical toxicity from methotrexate can result oral anticoagulant 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 adhesiveness and interferes with hemostasis in heparin-
Read more...treated patients pyrazinamide inhibits pyrazinamide-induced hyperuricemia uricosuric agents effect of probenecid, sulfinpyrazone and phenylbutazone inhibited the following alterations of laboratory tests have been reported during salicylate therapy ⶠ: laboratory tests effect of salicylates thyroid function decreased pbi; increased t 3 uptake urinary sugar false negative with glucose oxidase; false positive with clinitest with high-dose salicylate therapy (2-5 g qd) 5 hydroxyindole acetic acid false negative with fluorometric test acetone, ketone bodies false positive fecl 3 in gerhardt reaction; red color persists with boiling 17-oh corticosteroids false reduced values with >4.8 g qd salicylate vanilmandelic acid false reduced values uric acid may increase or decrease depending on dose prothrombin decreased levels; slightly increased prothrombin time
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 acetyl salicylic acid used in these studies to topical administration as the oral dose to monkeys may represent 4 times the maximum daily human dose of salicylic acid (as supplied in one tube, 40 g of keralyt gel) when applied topically over a large body surface. there are no adequate and well-controlled studies in pregnant women. keralyt gel should be used during pregnancy only if the potential benefit justifies the risk to the fetus.
Overdosage:
Overdosage - see warnings
Description:
Description: keralyt® is a gel for topical administration containing salicylic acid 6%, in a vehicle composed of propylene glycol, sd-40 alcohol (21%), hydroxypropylcellulose and purified water. salicylic acid is the 2 hydroxy derivative of benzoic acid having the following structure: salicylic acid structure
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. ¹ , ² the mechanism of action has been attributed to a dissolution of intercellular cement substance. ³ in a study of the percutaneous absorption of salicylic acid from keralyt gel in four patients with extensive active psoriasis, taylor and halprin ⴠshowed that 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 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
Read more... diuretics have higher salicylate levels than those with a normal extracellular space. ⵠ(see precautions ). the major metabolites identified in the urine after topical administration are salicyluric acid (52%), salicylate glucuronides (42%), and free salicylic acid (6%). ³ 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. ⵠfifty 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 competitive mechanisms other drugs can influence the serum levels of salicylate. ⵠ(see precautions ).
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility: no data are available concerning potential carcinogenic or reproductive effects of keralyt gel. it has been shown to lack mutagenic potential in the ames salmonella test.
Package Label Principal Display Panel:
Keralyt-100g-carton keralyt-100g-tube