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| Product NDC Code | 11086-047 | ||||
|---|---|---|---|---|---|
| Drug Name | Keralyt |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 212332, 312893, 667904, 866892, 883501, 999618 |
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| Labeler Name | SUMMERS LABORATORIES INC | ||||
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Overdosage of Keralyt
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.OVERDOSAGE - See WARNINGS
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.ADVERSE REACTIONS: Excessive erythema and scaling conceivably could result from use on open skin lesions.
Keralyt Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.Drug Interactions. (The following interactions are from a published review ⁵ 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-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 ⁶ : 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
| Drug | Description of Interaction |
| Tolbutamide; Sulfonylureas | Hypoglycemia potentiated |
| Methotrexate | Decreases tubular reabsorption; clinical toxicity from methotrexate can result |
| Oral Anticoagulant | Increased bleeding |
| Drug | Description |
| Corticosteroids | Decreases plasma salicylate level; Tapering doses of steroids may promote salicylism |
| Ammonium Sulfate | Increases plasma salicylate level |
| Drug | Description |
| Heparin | Salicylate decreases platelet adhesiveness and interferes with hemostasis in heparin-treated patients |
| Pyrazinamide | Inhibits pyrazinamide-induced hyperuricemia |
| Uricosuric Agents | Effect of probenecid, sulfinpyrazone and phenylbutazone inhibited |
| Laboratory Tests | Effect of Salicylates |
| Thyroid Function | Decreased PBI; increased T 3uptake |
| 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 3in 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 |
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.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 ⁴ showed 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 diuretics have higher salicylate levels than those with a normal extracellular space. ⁵ (See PRECAUTIONS ). The major metabolites identified in the urine after topical administration are salicyluric acid (52%), salicylate glucuronides (42%), and free salicylic acid (6%). ⁴ 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. ⁵ 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 competitive mechanisms other drugs can influence the serum levels of salicylate. ⁵ (See PRECAUTIONS ).
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.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.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.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:
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 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.
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.Keralyt ® Gel (salicylic acid) 6% FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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.
Spl product data elements
Usually a list of ingredients in a drug product.Keralyt salicylic acid Keralyt SALICYLIC ACID SALICYLIC ACID SALICYLIC ACID Keralyt SALICYLIC ACID SALICYLIC ACID SALICYLIC ACID
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.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
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.keralyte-figure-2a
References
This field may contain references when prescription drug labeling must summarize or otherwise relay on a recommendation by an authoritative scientific body, or on a standardized methodology, scale, or technique, because the information is important to prescribing decisions.REFERENCES: Davies M, Marks R: Br J Dermatol 95: 187-192,1976. Marks R, Davies M, Cattel A: J Invest Dermatol 64: 283, 1975. Huber C, Christophers E: Arch Derm Res 257: 293-297, 1977. Taylor JR, Halprin KM: Arch Dermatol 111: 740-743, 1975. Goldsmith LA: Int J Dermatol 18: 32-36. Wilson JG, Ritter EJ, Scott WJ, Fradlein R: Tox Appl Pharmacol 41: 67-78, 1977. SUMMERS LABORATORIES INC Manufactured by: EMS Contract Packaging, Hatfield, PA 19440 Distributed by: Summers Laboratories, Inc. Collegeville, PA 19426 1-800-533-SKIN (7546) • www.sumlab.com KERALYT is a trademark of Summers Laboratories, Inc.
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.Nursing Mothers: Because of the potential for serious adverse reactions in nursing infants from the mother’s use of KERALYT GEL, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)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.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED: 60 g Plastic bottle NDC 11086-030-60 Store at controlled room temperature 59° to 86° F (15° to 30° C)
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS: For external use only. Avoid contact with eyes and other mucous membranes. Mild burning or stinging may occur. 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. Flammable. Keep away from heat and open flame. Keep this and all medications out of reach of children. Drug Interactions. (The following interactions are from a published review ⁵ 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-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 ⁶ : 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 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. Nursing Mothers: Because of the potential for serious adverse reactions in nursing infants from the mother’s use of KERALYT GEL, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. 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.
| Drug | Description of Interaction |
| Tolbutamide; Sulfonylureas | Hypoglycemia potentiated |
| Methotrexate | Decreases tubular reabsorption; clinical toxicity from methotrexate can result |
| Oral Anticoagulant | Increased bleeding |
| Drug | Description |
| Corticosteroids | Decreases plasma salicylate level; Tapering doses of steroids may promote salicylism |
| Ammonium Sulfate | Increases plasma salicylate level |
| Drug | Description |
| Heparin | Salicylate decreases platelet adhesiveness and interferes with hemostasis in heparin-treated patients |
| Pyrazinamide | Inhibits pyrazinamide-induced hyperuricemia |
| Uricosuric Agents | Effect of probenecid, sulfinpyrazone and phenylbutazone inhibited |
| Laboratory Tests | Effect of Salicylates |
| Thyroid Function | Decreased PBI; increased T 3uptake |
| 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 3in 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 |
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 Reye's Syndrome, salicylate products should not be administered to children or teenagers with varicella or influenza, unless directed by a physician.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API