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NDC 52187-0525-10 XALIX 280 mg/g Details
XALIX 280 mg/g
XALIX is a TOPICAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by KMM Pharmaceuticals, LLC. The primary component is SALICYLIC ACID.
MedlinePlus Drug Summary
Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions that involve scaling or overgrowth of skin cells such as psoriasis (a skin disease in which red, scaly patches form on some areas of the body), ichthyoses (inborn conditions that cause skin dryness and scaling), dandruff, corns, calluses, and warts on the hands or feet. Topical salicylic acid should not be used to treat genital warts, warts on the face, warts with hair growing from them, warts in the nose or mouth, moles, or birthmarks. Salicylic acid is in a class of medications called keratolytic agents. Topical salicylic acid treats acne by reducing swelling and redness and unplugging blocked skin pores to allow pimples to shrink. It treats other skin conditions by softening and loosening dry, scaly, or thickened skin so that it falls off or can be removed easily.
Related Packages: 52187-0525-10Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Salicylic Acid Topical
Product Information
| NDC | 52187-0525 |
|---|---|
| Product ID | 52187-525_5c60df47-58d0-5226-e053-2a91aa0a1646 |
| Associated GPIs | 90750030002013 |
| GCN Sequence Number | 077932 |
| GCN Sequence Number Description | salicylic acid SOL-FILMER 28 % TOPICAL |
| HIC3 | L5A |
| HIC3 Description | KERATOLYTICS |
| GCN | 44102 |
| HICL Sequence Number | 002465 |
| HICL Sequence Number Description | SALICYLIC ACID |
| Brand/Generic | Brand |
| Proprietary Name | XALIX |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | SALICYLIC ACID |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | TOPICAL |
| Active Ingredient Strength | 280 |
| Active Ingredient Units | mg/g |
| Substance Name | SALICYLIC ACID |
| Labeler Name | KMM Pharmaceuticals, LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED DRUG OTHER |
| Application Number | n/a |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 52187-0525-10 (52187052510)
| NDC Package Code | 52187-525-10 |
|---|---|
| Billing NDC | 52187052510 |
| Package | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (52187-525-10) / 10 g in 1 BOTTLE, WITH APPLICATOR |
| Marketing Start Date | 2017-10-25 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 5c60df47-58cf-5226-e053-2a91aa0a1646 Details
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:
CLINICAL PHARMACOLOGY:
INDICATIONS AND USAGE:
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.
WARNINGS:
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.
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.
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.
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
INGREDIENTS AND APPEARANCE
| XALIX
salicylic acid solution |
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| Labeler - KMM Pharmaceuticals, LLC (078521761) |