Salicylic Acid 28.5% Solution

Salicylic Acid 28.5% Solution
SPL v1
SPL
SPL Set ID 4136d85b-8b73-08e7-e063-6394a90a353b
Route
TOPICAL
Published
Effective Date 2025-10-15
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (285 mg)

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-10-20

Description

Rx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

Indications and Usage

This product is indicated for the topical treatment and removal of common warts and plantar warts.

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

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.

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.

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


Medication Information

Indications and Usage

This product is indicated for the topical treatment and removal of common warts and plantar warts.

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

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.

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.

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

Description

Rx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

Section 51945-4

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:

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

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.

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.

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.

Indications and Usage:

This product is indicated for the topical treatment and removal of common warts and plantar warts.

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.

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.

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.

Salicylic Acid 28.5% Solution (salicylic Acid 28.5% Extended Release)



Rx Only

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.


Structured Label Content

Section 51945-4 (51945-4)

Description: (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:

How Supplied: (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

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.

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.

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.

Indications and Usage: (INDICATIONS AND USAGE:)

This product is indicated for the topical treatment and removal of common warts and plantar warts.

Dosage and Administration: (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.

Warnings: Keep Out of Reach of Children. (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.

Precautions: for External Use Only. Not for Ophthalmic Use. (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.

Salicylic Acid 28.5% Solution (salicylic Acid 28.5% Extended Release) (Salicylic Acid 28.5% Solution (salicylic acid 28.5% extended release))



Rx Only

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.


Advanced Ingredient Data


Raw Label Data

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