Sophtal is a topical preparation containing 27.5% Sophtal in a proprietary film-forming vehicle that comprises isopropyl alcohol, butyl acetate, polyvinyl butyral, isopropyl metacresol, trimethyl pentanyl diisobutyrate, phenic acid and acrylates copolymer. The pharmacologic activity of Sophtal is generally attributed to the keratolytic activity of Sophtal which is incorporated into a polyacrylic, film-forming virucidal vehicle designed to cover the wart without the need for a bandage. The structural formula of Sophtal is:

CLINICAL PHARMACOLOGY

Although the exact mode of action for Sophtal 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.

The virucidal complex incorporated into Sophtal’s proprietary vehicle is designed to help reduce risk of reinfection at the wart site, as well as prevent viral contamination of the product under normal usage.

INDICATIONS AND USAGE

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

CONTRAINDICATIONS

Patients with diabetes or impaired blood circulation should not use Sophtal. Sophtal also should not be used on moles, birthmarks, and unusual warts with hair growing from them, or warts on the face.

PRECAUTIONS

Sophtal is for external use only. Do not permit Sophtal to contact eyes or mucous membranes. If contact with eyes or mucous membranes occurs, immediately flush with water for 15 minutes. Sophtal should not be allowed to contact normal skin surrounding wart, since localized irritation may occur. Treatment should be discontinued if excessive irritation occurs. Sophtal is flammable. Keep away from fire or flame. Keep bottle tightly capped when not in use.

ADVERSE REACTIONS

A localized irritant reaction may occur if Sophtal 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 ADMINISTRATION

Prior to applying Sophtal, soak wart in warm water for five minutes. Remove any loosened tissue by gently rubbing with a brush, wash cloth, or emery board. Dry wart site thoroughly. Using the brush applicator supplied, apply Sophtal twice to entire wart surface, allowing the first application to dry before applying the second. Continue treatment once or twice a day 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 Sophtal use.

HOW SUPPLIED

Sophtal is supplied in 10ml amber bottles with a brush applicator (NDC 42783-312-10).

Store at controlled room temperature, 15° to 30°C (59° to 86°F).

Manufactured for:

Elorac, Inc.

Vernon Hills, IL 60061

U.S. Patent Pending

Revised 06/2011

221619

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Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to Sophtal or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Young children may be at increased risk of unwanted effects because of increased absorption of Sophtal through the skin. Also, young children may be more likely to get skin irritation from Sophtal. Sophtal should not be applied to large areas of the body, used for long periods of time, or used under occlusive dressing (air-tight covering, such as kitchen plastic wrap) in infants and children. Sophtal should not be used in children younger than 2 years of age.

Geriatric

Elderly people are more likely to have age-related blood vessel disease. This may increase the chance of problems during treatment with Sophtal.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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References

DailyMed. "CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
FDA/SPL Indexing Data. "R4KO0DY52L: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

Sophtal Dosage

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