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Walk the Even Hospital Database by book and chapter — the raw source passages that ground Ask, DDx, and the rest.

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spl_unclassified_sectionopenfda· Spl Unclassified Section· item 1095689

Wart Remover Rx Only FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE. STEP 1: WASH Soak wart area in warm water for about 5 minutes. Remove any loose tissue using a wash cloth, emery board or pumice stone. Dry thoroughly. STEP 2: BRUSH Using the brush applicator supplied, apply twice to entire wart surface, allowing the first application to dry before applying the second. Be careful not to apply to surrounding skin. Leave Salicylic Acid, 27.5% Wart Remover on wart area after it dries. Repeat Step 1 and Step 2 once or twice daily as advised by your health care provider. Clinically visible improvement will normally occur during the first or second week of therapy. MANUFACTURED FOR: Acella Pharmaceuticals, LLC Alpharetta, GA 30009 1-800-541-4802 Rev. 0611

descriptionopenfda· Description· item 1095689

DESCRIPTION: Salicylic Acid, 27.5% Wart Remover is a topical preparation containing 27.5% salicylic acid in a film-forming vehicle composed of isopropyl alcohol, isobutyrate, acrylates copolymer, N butyl acetate and polyvinyl butyrate. The pharmacologic activity of Salicylic Acid, 27.5% Wart Remover is generally attributed to the keratolytic activity of salicylic acid which is incorporated into a film-forming vehicle designed to cover the wart without the need for a bandage. The structural formula of salicylic acid is: mm1

clinical_pharmacologyopenfda· Clinical Pharmacology· item 1095689

CLINICAL PHARMACOLOGY: Although the exact mode of action for salicylic acid in the treatment of warts is not known, its activity appears to be associated with its keratolytic action which results in mechanical removal of epidermal cells infected with wart viruses.

contraindicationsopenfda· Contraindications· item 1095689

CONTRAINDICATIONS: Salicylic Acid, 27.5% Wart Remover should not be used by diabetics or patients with impaired blood circulation. Salicylic Acid, 27.5% Wart Remover should not be used on moles, birthmarks, unusual warts with hair growing from them or warts on the face.

precautionsopenfda· Precautions· item 1095689

PRECAUTIONS: Salicylic Acid, 27.5% Wart Remover is for external use only. Do not permit Salicylic Acid, 27.5% Wart Remover to contact eyes or mucous membranes. If contact with eyes or mucous membranes occurs, immediately flush with water for 15 minutes. Salicylic Acid, 27.5% Wart Remover should not be allowed to contact normal skin surrounding wart. Treatment should be discontinued if excessive irritation occurs. Salicylic Acid, 27.5% Wart Remover is flammable and should be kept away from fire or flame. Keep bottle tightly capped when not in use. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

adverse_reactionsopenfda· Adverse Reactions· item 1095689

ADVERSE REACTIONS: A localized irritant reaction may occur if Salicylic Acid, 27.5% Wart Remover is applied to the normal skin surrounding the wart. Any irritation may normally be controlled by temporarily discontinuing use and by applying the medication only to the wart site when treatment is resumed.

dosage_and_administrationopenfda· Dosage and Administration· item 1095689

DOSAGE AND ADMINISTRATION: Prior to application of Salicylic Acid, 27.5% Wart Remover, soak wart in warm water for five minutes. Remove any loosened tissue by gently rubbing with a brush, wash cloth or emery board. Dry thoroughly. Using the brush applicator supplied, apply twice to entire wart surface, allowing the first application to dry before applying the second. Treatment should be once or twice a day and should continue as directed by physician. Be careful not to apply to surrounding skin. Clinically visible improvement will normally occur during the first or second week of therapy. Maximum resolution may be expected after four to six weeks of use.

instructions_for_useopenfda· Instructions For Use· item 1095689

PATIENT INSTRUCTIONS: Your health care provider has prescribed Salicylic Acid, 27.5% Wart Remover, a topical prescription preparation for the treatment of common and plantar warts. In order for Salicylic Acid, 27.5% Wart Remover to work correctly and to ensure maximum benefit, the following instructions should be followed carefully. Of course, as with any medication, always consult your health care provider if you experience any discomfort or unexpected reactions.

descriptionopenfda· Description· item 1487371

DESCRIPTION: Each mL contains 285 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_pharmacologyopenfda· Clinical Pharmacology· item 1487371

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.

contraindicationsopenfda· Contraindications· item 1487371

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.

precautionsopenfda· Precautions· item 1487371

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_reactionsopenfda· Adverse Reactions· item 1487371

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_administrationopenfda· Dosage and Administration· item 1487371

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_suppliedopenfda· How Supplied· item 1487371

HOW SUPPLIED: 1/3 fl. oz. (10 mL) bottles, NDC 24470-948-10 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 2500269 [00] Rev. 10/2025

descriptionopenfda· Description· item 1986360

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

how_suppliedopenfda· How Supplied· item 1986360

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