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| Product NDC Code | 52187-525 | ||||
|---|---|---|---|---|---|
| Drug Name | Xalix |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 1986360, 1986365 |
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| Labeler Name | KMM Pharmaceuticals, LLC | ||||
| Packages |
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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: Localized irritation may occur if this product is applied to normal skin surrounding the wart; however irritation may normally be controlled by temporarily discontinuing use and by applying the medication only to the wart site when treatment is resumed. To report a serious adverse event, call 1-855-899-4237.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY: Although the exact mode of action for salicylic acid in the treatment of warts is unknown, its activity appears to be associated with its keratolytic action, which results in mechanical removal of epidermal cells infected with wart viruses.
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: This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. Patients with diabetes or impaired blood circulation should not use this product. This product also should not be used on moles, birthmarks, and unusual warts with hair growing from them, or warts on the face.
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: Each gram contains 280 mg of salicylic acid extended release in a film-forming virucidal solution consisting of acrylates copolymer, isopropyl alcohol, n-Butyl acetate, polyvinyl butyral, and trimethyl pentanyl diisobutyrate. The pharmacologic activity of this product is generally attributed to the keratolytic activity of salicylic acid, which is incorporated into a polyacrylic, film-forming virucidal solution designed to cover the wart without the need for a bandage. The structural formula of salicylic acid is: 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: Prior to applying this product, soak wart in warm water for five minutes. Remove any loose tissue by gently rubbing with a washcloth, emery board, or pumice stone. Dry the wart site thoroughly. Using the brush applicator supplied, apply this product twice to the entire wart surface, allowing the first application to dry before applying the second. Continue treatment once or twice a day or as directed by a physician. Be careful not to apply to surrounding skin. Clinically visible improvement normally occurs during the first or second week of therapy. Resolution may be expected after four to six weeks of this product’s use, though some warts may take longer to remove.
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: This product is indicated for the topical treatment and removal of common warts and plantar warts.
Spl product data elements
Usually a list of ingredients in a drug product.XALIX SALICYLIC ACID SALICYLIC ACID SALICYLIC ACID
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.carton
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Rx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
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: 10 g bottles, NDC 52187-525-10 Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. Protect from freezing and excessive heat. Keep bottle tightly closed. Manufactured for: KMM Pharmaceuticals, LLC 1000 N. West Street Suite 1200, #1021 Wilmington, DE 19801
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. If contact with eyes or mucous membranes occurs, immediately flush with water for 15 minutes. This product should not be allowed to contact normal skin surrounding the wart site, since localized irritation may occur. Treatment should be discontinued if excessive irritation occurs.
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: KEEP OUT OF REACH OF CHILDREN. This product is flammable. Keep away from fire or flame. Keep bottle tightly closed when not in use.
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