Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameSALICYLIC ACID
Labeler / manufacturerCintex Services, LLC
RouteTOPICAL
Drug classDrug class not supplied in source label
Product NDC24470-947
Label effective date2025-10-15
Official product label reference
Xalix — Cintex Services, LLC
This page contains 10 source sections for SALICYLIC ACID, topical route. Label set 41369b38-7f15-b597-e063-6394a90a614b, version 1.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
INDICATIONS AND USAGE: This product is indicated for the topical treatment and removal of common warts and plantar warts.
Dosage and administration — label text
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.
Contraindications
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
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.
Adverse reactions
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.
Unclassified section
Rx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
Product description
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
Clinical pharmacology
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.
Precautions
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.
Supply and packaging
HOW SUPPLIED: 10 g bottles, NDC 24470-947-10 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: Cintex Services, LLC Dallas, TX 75243 2500188 [00] Rev. 07/2025
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.