Name of the medicinal product

Septisol

Therapeutic indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

For Dermatologic Use: Septisol 6% is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders including verrucae, and the various ichthyoses (vulgaris, sex-linked and lamellar), keratosis palmaris and plantaris keratosis pilaris, pityriasis rubra pilaris, and psoriasis (including body, scalp, palms and soles).

For Podiatric Use: Septisol 6% is a topical aid in the removal of excessive keratin on dorsal and plantar hyperkeratotic lesions.

Topical preparations of 6% Septisol have been reported to be useful adjunctive therapy for verrucae plantares.

Septisol is a keratolytic (peeling agent). Septisol causes shedding of the outer layer of skin.

Septisol topical (for the skin) is used in the treatment of acne, dandruff, seborrhea, or psoriasis, and to remove corns, calluses, and warts.

Septisol topical may also be used for purposes not listed in this medication guide.

Dosage (Posology) and method of administration

Rx only

FOR TOPICAL USE ONLY.

NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.

DESCRIPTION

Virasal is a topical preparation containing 27.5% Septisol 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 Virasal is generally attributed to the keratolytic activity of Septisol 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 Septisol is:

CLINICAL PHARMACOLOGY

Although the exact mode of action for Septisol 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 Virasal’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

Virasal 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 Virasal. Virasal also should not be used on moles, birthmarks, and unusual warts with hair growing from them, or warts on the face.

PRECAUTIONS

Virasal is for external use only. Do not permit Virasal to contact eyes or mucous membranes. If contact with eyes or mucous membranes occurs, immediately flush with water for 15 minutes. Virasal should not be allowed to contact normal skin surrounding wart, since localized irritation may occur. Treatment should be discontinued if excessive irritation occurs. Virasal 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 Virasal 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 Virasal, 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 Virasal 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 Virasal use.

HOW SUPPLIED

Virasal 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

Contraindications

Less common or rare

Skin irritation not present before use of Septisol (moderate or severe)

Frequency not known

Dryness and peeling of skin

flushing

redness of skin

unusually warm skin

Symptoms of Septisol poisoning

Confusion

diarrhea

dizziness

fast or deep breathing

headache (severe or continuing)

hearing loss

lightheadedness

nausea

rapid breathing

ringing or buzzing in ears (continuing)

severe drowsiness

stomach pain

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

-Skin irritation not present before use of Septisol (mild) -stinging

Special warnings and precautions for use

Use Septisol shampoo as directed by your doctor. Check the label on the medicine for exact dosing instructions.

To use shampoo as a scalp treatment: Use before bathing. Do not wet hair. Apply Septisol shampoo with the applicator directly to affected areas of the scalp. Leave on for 5 minutes, gradually increasing the treatment time up to 1 hour, or as directed by your doctor. After treatment, rinse thoroughly with water. Wash your hands after each use. You may use a non-medicated shampoo after using Septisol shampoo, if desired.
To use shampoo as a medicated shampoo: Wet hair, apply Septisol shampoo with the applicator directly to scalp, and massage vigorously for several minutes. Rinse thoroughly. Be sure to wash your hands after each use. Use Septisol shampoo daily until the condition clears, or as directed by your doctor.
To use the gel on the skin: Moisten the affected area and keep damp for at least 5 minutes before you apply Septisol shampoo. Apply Septisol shampoo to the affected area as directed. Cover the treated area at night unless your doctor tells you otherwise. If applying to an area that cannot be covered, check with your doctor for instructions. Wash Septisol shampoo off in the morning.
To use gel as a scalp treatment: Apply Septisol shampoo with the applicator directly to affected areas of the scalp. Avoid contact with unaffected hair or skin. Leave the medicine on for 10 to 20 minutes initially, gradually increasing the treatment time to one hour, or as directed by your doctor. The gel may be washed off using the medicated shampoo or warm water in a bath or shower.
Wash hands immediately after you use Septisol shampoo, unless your hands are part of the treated area.
If you miss a dose of Septisol shampoo, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Septisol shampoo.

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.

This medication is used on the skin to treat common skin and foot (plantar) warts. Septisol helps cause the wart to gradually peel off. This medication is also used to help remove corns and calluses. This product should not be used on the face or on moles, birthmarks, warts with hair growing from them, or genital/anal warts.

Septisol is a keratolytic. It belongs to the same class of drugs as aspirin (salicylates). It works by increasing the amount of moisture in the skin and dissolving the substance that causes the skin cells to stick together. This makes it easier to shed the skin cells. Warts are caused by a virus. Septisol does not affect the virus.

How to use Septisol topical

Follow all directions on the product package. If you are uncertain about any of the information, consult your doctor or pharmacist.

This medication is for use on the skin only. To avoid irritation, do not let this medication come into contact with your eyes, nose, mouth, groin, or any broken skin. If you do get the medication in those areas, flush the area with cool water for 15 minutes. Wash hands after use.

First, soak the corn, callus, or wart in warm water for about 5 minutes to soften the treatment area. Dry thoroughly. Your doctor may direct you to use a pumice stone, callus file, or emery board to carefully remove the top dead layers of skin after soaking and before applying the medication. This dead skin removal is only to help the medication work better. Do not try to rub the wart or callus off.

If you are using a liquid/gel, apply a few drops or a thin coat of the medication to cover the entire wart, callus, or corn using the applicator if provided. Be careful to apply it only to the affected area and not the surrounding skin. Let dry for 5 minutes. Depending on the brand used, you may need to apply the medication twice with each treatment. Check your product package and follow the directions carefully. You may cover the area loosely with a bandage. Repeat this procedure 1 to 2 times daily for up to 2 weeks for corns and calluses and 12 weeks for warts or as directed by your doctor.

If you are using a medicated pad or bandage, you may need to cut the pad so that it covers the treatment area completely but does not touch the surrounding skin. Peel off the protective covering and place the patch/bandage over the area. Leave in place according to package directions. Remove and place a new patch/bandage as directed (usually every 8 to 48 hours depending on brand). Repeat this procedure for up to 2 weeks for corns and calluses and 12 weeks for warts.

Dosage is based on your medical condition, product type/brand, and response to treatment. Do not use large amounts, apply this medication more often, or use it for a longer period than directed. Your condition will not clear faster, but the chance for side effects may be increased.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.

If your condition persists or worsens, or if you think you may have a serious medical problem, seek immediate medical attention.

Interaction with other medicinal products and other forms of interaction

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to Septisol 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 Septisol through the skin. Also, young children may be more likely to get skin irritation from Septisol. Septisol 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. Septisol 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 Septisol.

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.

Undesirable effects