Collomak

Lactic Acid (Collomak) (Lactic Acid (Collomak)) is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these conditions.

Mouth/Throat

Mouth lesions

Adult: As dental preparation containing deproteinised calf's blood extract 5% and polidocanol 1%: Apply to lesions 3-5 times daily after drying the area with gauze or cotton. Do not rub in the paste.

For Dermatologic Use: Salicylic Acid (Collomak) 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: Salicylic Acid (Collomak) 6% is a topical aid in the removal of excessive keratin on dorsal and plantar hyperkeratotic lesions.

Topical preparations of 6% Salicylic Acid (Collomak) have been reported to be useful adjunctive therapy for verrucae plantares.

Moisturizing and softening dry, scaly skin (xerosis) and ichthyosis vulgaris, and for the temporary relief of itching associated with these conditions.

Lactic Acid (Collomak) is a humectant. Exactly how it works is unknown but it increases the amount of water in the skin, making it softer and more pliable.

Salicylic Acid (Collomak) is a keratolytic (peeling agent). Salicylic Acid (Collomak) causes shedding of the outer layer of skin.

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

Salicylic Acid (Collomak) topical may also be used for purposes not listed in this medication guide.

Shake well. Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.

How supplied

Lactic Acid (Collomak)® (ammonium lactate) Lotion, 12% is available in a 225g (NDC 0072-5712-08) plastic bottle and a 400g (NDC 0072-5712-14) plastic bottle.

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

Manufactured for: Bristol-Myers Squibb Co. Princeton, NJ 08543 USA. by: Contract Pharmaceuticals Limited Niagara Buffalo, NY 14213 USA. FDA revision date: 11/9/2007

Mouth/Throat

Mouth lesions

Adult: As dental preparation containing deproteinised calf's blood extract 5% and polidocanol 1%: Apply to lesions 3-5 times daily after drying the area with gauze or cotton. Do not rub in the paste.

Rx only

FOR TOPICAL USE ONLY.

NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.

DESCRIPTION

Virasal is a topical preparation containing 27.5% Salicylic Acid (Collomak) 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 Salicylic Acid (Collomak) 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 Salicylic Acid (Collomak) is:

CLINICAL PHARMACOLOGY

Although the exact mode of action for Salicylic Acid (Collomak) 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

See also:
What is the most important information I should know about Lactic Acid (Collomak)?

Lactic Acid (Collomak) (Lactic Acid (Collomak)) Lotion is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.

Hypersensitivity. Patients w/ acute severe disease, bedridden or unable to walk, arterial occlusive disease Fontaine stage III & IV, thromboembolic diseases, thrombosis eg, patients born w/ a tendency for blood clots or w/ several risk factors eg, use of hormonal contraceptives or hormone replacement therapy, overwt, smoking, extended periods of immobility; & known symptomatic patent foramen ovale.

See also:
What is the most important information I should know about Salicylic Acid (Collomak)?

Less common or rare

Skin irritation not present before use of Salicylic Acid (Collomak) (moderate or severe)

Frequency not known

Dryness and peeling of skin

flushing

redness of skin

unusually warm skin

Symptoms of Salicylic Acid (Collomak) 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 Salicylic Acid (Collomak) (mild) -stinging

Use Lactic Acid (Collomak) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Apply Lactic Acid (Collomak) to the affected area and rub in thoroughly twice daily or as directed by your health care provider.
• Wash your hands immediately after using Lactic Acid (Collomak), unless your hands are part of the treated area.
• If you miss a dose of Lactic Acid (Collomak), 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 Lactic Acid (Collomak).

Use Salicylic Acid (Collomak) 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 Salicylic Acid (Collomak) 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 Salicylic Acid (Collomak) shampoo, if desired.
• To use shampoo as a medicated shampoo: Wet hair, apply Salicylic Acid (Collomak) 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 Salicylic Acid (Collomak) 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 Salicylic Acid (Collomak) shampoo. Apply Salicylic Acid (Collomak) 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 Salicylic Acid (Collomak) shampoo off in the morning.
• To use gel as a scalp treatment: Apply Salicylic Acid (Collomak) 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 Salicylic Acid (Collomak) shampoo, unless your hands are part of the treated area.
• If you miss a dose of Salicylic Acid (Collomak) 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 Salicylic Acid (Collomak) shampoo.

Some brands of this product are used on the skin to treat common skin and foot (plantar) warts, while other brands are used to remove corns and calluses.

This product contains 2 main ingredients. Salicylic acid is a keratolytic. It belongs to the same class of drugs as aspirin (salicylates). It works by breaking down the thick top layer of skin and increasing the amount of moisture in the skin. It causes the wart, corn, or callus to gradually peel off. Flexible collodion works by forming a protective coating over the treated area. It helps to keep the area clean and also keeps the salicylic acid and moisture in contact with the skin.

This product should not be used on the face or on moles, birthmarks, warts with hair growing from them, or genital/anal warts.

If you are self-treating with this medication, it is important to read the package instructions carefully before you start using this product to be sure it is right for you.

How to use Lactic Acid (Collomak) topical

Use this product on the skin as directed by your doctor. If you are self-treating, follow all directions on the product package. If you are uncertain about any of the information, ask your doctor or pharmacist.

First wash the affected area. You may soak it in warm water for about 5 minutes to soften it. Dry thoroughly. Your doctor may direct you to use a rough towel, pumice stone, callus file, or emery board to gently remove the top dead layers of thickened skin after soaking and before applying the liquid. Do not use sharp objects. Removing the dead skin helps the medication to work better. Do not try to rub the wart, corn, or callus off.

Using the applicator provided, apply a thin coat of the medication (one drop at a time) to cover the entire wart, corn, or callus. To minimize irritation, be careful not to get the liquid on surrounding skin. Let dry. Repeat this procedure 1 to 2 times daily as needed until the wart, corn, or callus is removed. For warts, you may use this product for up to 12 weeks. For corns and calluses, you may use it for up to 2 weeks. Wash hands after use.

Do not use this product on skin that is irritated, red, or infected. Avoid contact with the eyes and face. If this product gets on these areas or on healthy surrounding skin, wash it off right away. Flush the eyes with water for 15 minutes. If irritation persists, contact your doctor right away.

Do not apply a large amount of this medication or apply it to a large area. Do not use it more often or for longer than directed. Your condition will not improve any faster, and your risk of side effects will increase.

Avoid inhaling the fumes from this product.

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

This medication is used on the skin to treat common skin and foot (plantar) warts. Salicylic Acid (Collomak) 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.

Salicylic Acid (Collomak) 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. Salicylic Acid (Collomak) does not affect the virus.

How to use Salicylic Acid (Collomak) 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.

See also:
What other drugs will affect Lactic Acid (Collomak)?

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Keep a list of all the products you use. Share the list with your doctor and pharmacist to reduce your risk for serious medication problems.

May enhance the effect on CVS w/ other local anaesth.

See also:
What other drugs will affect Salicylic Acid (Collomak)?

Allergies

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

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.

See also:
What are the possible side effects of Lactic Acid (Collomak)?

In controlled clinical trials of patients with ichthyosis vulgaris, the most frequent adverse reactions in patients treated with Lactic Acid (Collomak) were rash (including erythema and irritation) and burning/stinging. Each was reported in approximately 10-15% of patients. In addition, itching was reported in approximately 5% of patients.

In controlled clinical trials of patients with xerosis, the most frequent adverse reactions in patients treated with Lactic Acid (Collomak) were transient burning, in about 3% of patients, stinging, dry skin and rash, each reported in approximately 2% of patients.

Neovascularization, haematoma; hyperpigmentation, ecchymosis; pain at the inj site (short-term), thrombosis at the inj site.

See also:
What are the possible side effects of Salicylic Acid (Collomak)?

Less common or rare

Skin irritation not present before use of Salicylic Acid (Collomak) (moderate or severe)

Frequency not known

Dryness and peeling of skin

flushing

redness of skin

unusually warm skin

Symptoms of Salicylic Acid (Collomak) 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 Salicylic Acid (Collomak) (mild) -stinging

A normal intermediate in the fermentation (oxidation, metabolism) of sugar. The concentrated form is used internally to prevent gastrointestinal fermentation. (From Stedman, 26th ed) Sodium lactate is the sodium salt of Lactic Acid (Collomak), and has a mild saline taste. It is produced by fermentation of a sugar source, such as corn or beets, and then, by neutralizing the resulting Lactic Acid (Collomak) to create a compound having the formula NaC3H5O3.

Each mL contains anthraquinone glycosides 50 mg, Salicylic Acid (Collomak) 10 mg and alcohol 60%.