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|Off-Ezy Topical Solution Wart Removal Kit Topical

SALICYLIC ACID (Topical)

Some commonly used brand names are:

In the U.S.—

• Antinea
• Buf-Puf Acne Cleansing Bar with Vitamin E
• Calicylic Creme
• Clearasil Clearstick Maximum Strength Topical Solution
• Clearasil Clearstick Regular Strength Topical Solution
• Clearasil Double Textured Pads Maximum Strength
• Clearasil Double Textured Pads Regular Strength
• Clearasil Medicated Deep Cleanser Topical Solution
• Clear Away
• Clear by Design Medicated Cleansing Pads
• Compound W Gel
• Compound W Liquid
• Duofilm
• Duoplant Topical Solution
• Freezone
• Gordofilm
• Hydrisalic
• Ionax Astringent Skin Cleanser Topical Solution
• Ionil Plus Shampoo
• Ionil Shampoo
• Keralyt
• Keratex Gel
• Lactisol
• Listerex Golden Scrub Lotion
• Listerex Herbal Scrub Lotion
• Mediplast
• Noxzema Anti-Acne Gel
• Noxzema Anti-Acne Pads Maximum Strength
• Noxzema Anti-Acne Pads Regular Strength
• Occlusal-HP Topical Solution
• Occlusal Topical Solution
• Off-Ezy Topical Solution Corn & Callus Remover Kit
• Off-Ezy Topical Solution Wart Removal Kit
• Oxy Clean Medicated Cleanser
• Oxy Clean Medicated Pads Maximum Strength
• Oxy Clean Medicated Pads Regular Strength
• Oxy Clean Medicated Pads Sensitive Skin
• Oxy Night Watch Maximum Strength Lotion
• Oxy Night Watch Sensitive Skin Lotion
• Paplex
• Paplex Ultra
• Propa pH Medicated Acne Cream Maximum Strength
• Propa pH Medicated Cleansing Pads Maximum Strength
• Propa pH Medicated Cleansing Pads Sensitive Skin
• Propa pH Perfectly Clear Skin Cleanser Topical Solution Normal/Combination Skin
• Propa pH Perfectly Clear Skin Cleanser Topical Solution Oily Skin
• Propa pH Perfectly Clear Skin Cleanser Topical Solution Sensitive Skin Formula
• P&S
• Salac
• Salacid
• Sal-Acid Plaster
• Salactic Film Topical Solution
• Sal-Clens Plus Shampoo
• Sal-Clens Shampoo
• Saligel
• Salex
• Salonil
• Sal-Plant Gel Topical Solution
• Sebucare
• Stri-Dex Dual Textured Pads Maximum Strength
• Stri-Dex Dual Textured Pads Regular Strength
• Stri-Dex Dual Textured Pads Sensitive Skin
• Stri-Dex Maximum Strength Pads
• Stri-Dex Regular Strength Pads
• Stri-Dex Super Scrub Pads
• Trans-Plantar
• Trans-Ver-Sal
• Verukan-HP Topical Solution
• Verukan Topical Solution
• Viranol
• Viranol Ultra
• Wart-Off Topical Solution
• X-Seb

In Canada—

• Compound W Gel
• Compound W Liquid
• Cuplex Gel
• Occlusal-HP Topical Solution
• Occlusal Topical Solution
• Oxy Clean Extra Strength Medicated Pads
• Oxy Clean Extra Strength Cleanser Topical Solution
• Oxy Clean Medicated Soap
• Oxy Clean Regular Strength Medicated Cleanser Topical Solution
• Oxy Clean Regular Strength Medicated Pads
• Oxy Clean Sensitive Skin Cleanser Topical Solution
• Oxy Clean Sensitive Skin Pads
• Oxy Night Watch Night Time Acne Medication Extra Strength Lotion
• Oxy Night Watch Night Time Acne Medication Regular Strength Lotion
• Oxy Sensitive Skin Vanishing Formula Lotion
• Salac
• Tersac Cleansing Gel
• Trans-Ver-Sal

Generic name product may be available in the U.S.

Category

• Antiacne agent, topical
• Antipsoriatic, topical
• Antiseborrheic
• Caustic
• Keratolytic, topical

Description

Salicylic acid (sal-i-SILL-ik AS-id) is used to treat many skin disorders, such as acne, dandruff, psoriasis, seborrheic dermatitis of the skin and scalp, calluses, corns, common warts, and plantar warts, depending on the dosage form and strength of the preparation.

Some of these preparations are available only with your doctor"s prescription. Others are available without a prescription; however, your doctor may have special instructions on the proper use of salicylic acid for your medical condition.

Salicylic acid is available in the following dosage forms:

• Topical
• Cream (U.S.)
• Gel (U.S. and Canada)
• Lotion (U.S. and Canada)
• Ointment (U.S.)
• Pads (U.S. and Canada)
• Plaster (U.S. and Canada)
• Shampoo (U.S.)
• Soap (U.S. and Canada)
• Topical solution (U.S. and Canada)

Before Using This Medicine

If you are using this medicine without a prescription, carefully read and follow any precautions on the label. For salicylic acid, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to salicylic acid. Also tell your health care professional if you are allergic to any other substances, such as preservatives or dyes.

Pregnancy—This medicine may be absorbed through the mother"s skin. Salicylic acid has not been studied in pregnant women. However, studies in animals have shown that salicylic acid causes birth defects when given orally in doses about 6 times the highest dose recommended for topical use in humans. Before using this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant, especially if you will be using salicylic acid on large areas of your body.

Breast-feeding—Salicylic acid may be absorbed through the mother"s skin. However, topical salicylic acid has not been reported to cause problems in nursing babies. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—Young children may be at increased risk of unwanted effects because of increased absorption of salicylic acid through the skin. Also, young children may be more likely to get skin irritation from salicylic acid. Salicylic acid 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 should not be used in children younger than 2 years of age.

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

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are using any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems—The presence of other medical problems may affect the use of salicylic acid, especially if you are using a 5% or stronger salicylic acid preparation. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood vessel disease

• Diabetes mellitus (sugar diabetes)—Use of this medicine may cause severe redness or ulceration, especially on the hands or feet

• Inflammation, irritation, or infection of the skin—Use of this medicine may cause severe irritation if applied to inflamed, irritated, or infected area of the skin

• Influenza (flu) or
• Varicella (chicken pox)—This medicine should not be used in children and teenagers with the flu or chicken pox. There is a risk of Reye"s syndrome.

• Kidney disease or
• Liver disease—Using this medicine for a long time over large areas could result in unwanted effects

Proper Use of This Medicine

It is very important that you use this medicine only as directed . Do not use more of it, do not use it more often, and do not use it for a longer time than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of absorption through the skin and the chance of salicylic acid poisoning.

If your doctor has ordered an occlusive dressing (airtight covering, such as kitchen plastic wrap) to be applied over this medicine, make sure you know how to apply it. Since an occlusive dressing will increase the amount of medicine absorbed through your skin and the possibility of salicylic acid poisoning, use it only as directed. If you have any questions about this, check with your doctor.

Keep this medicine away from the eyes and other mucous membranes , such as the mouth and inside of the nose. If you should accidentally get some in your eyes or on other mucous membranes, immediately flush them with water for 15 minutes.

To use the cream, lotion, or ointment form of salicylic acid:

• Apply enough medicine to cover the affected area, and rub in gently.

To use the gel form of salicylic acid:

• Before using salicylic acid gel, apply wet packs to the affected areas for at least 5 minutes. If you have any questions about this, check with your health care professional.
• Apply enough gel to cover the affected areas, and rub in gently.

To use the pad form of salicylic acid:

• Wipe the pad over the affected areas.
• Do not rinse off medicine after treatment.

To use the plaster form of salicylic acid for warts, corns, or calluses:

• This medicine comes with patient instructions. Read them carefully before using.
• Do not use this medicine on irritated skin or on any area that is infected or reddened. Also, do not use this medicine if you are a diabetic or if you have poor blood circulation .
• Do not use this medicine on warts with hair growing from them or on warts on the face, in or on the genital (sex) organs, or inside the nose or mouth. Also do not use on moles or birthmarks . To do so may cause severe irritation.
• Wash the area to be treated and dry thoroughly. Warts may be soaked in warm water for 5 minutes before drying.
• Cut the plaster to fit the wart, corn, or callus and apply.
• For corns and calluses:
  • Repeat every 48 hours as needed for up to 14 days, or as directed by your doctor, until the corn or callus is removed.
  • Corns or calluses may be soaked in warm water for 5 minutes to help in their removal.
• For warts:
  • Depending on the product, either:
    • Apply plaster and repeat every 48 hours as needed, or
      • Apply plaster at bedtime, leave in place for at least 8 hours, remove plaster in the morning, and repeat every 24 hours as needed.
  • Repeat for up to 12 weeks as needed, or as directed by your doctor, until wart is removed.
• If discomfort gets worse during treatment or continues after treatment, or if the wart spreads, check with your doctor.

To use the shampoo form of salicylic acid:

• Before applying this medicine, wet the hair and scalp with lukewarm water. Apply enough medicine to work up a lather and rub well into the scalp for 2 or 3 minutes, then rinse. Apply the medicine again and rinse thoroughly.

To use the soap form of salicylic acid:

• Work up a lather with the soap, using hot water, and scrub the entire affected area with a washcloth or facial sponge or mitt.
• If you are to use this soap in a foot bath, work up rich suds in hot water and soak the feet for 10 to 15 minutes. Then pat dry without rinsing.

To use the topical solution form of salicylic acid for acne:

• Wet a cotton ball or pad with the topical solution and wipe the affected areas.
• Do not rinse off medicine after treatment.

To use the topical solution form of salicylic acid for warts, corns, or calluses:

• This medicine comes with patient instructions. Read them carefully before using.
• This medicine is flammable. Do not use it near heat or open flame or while smoking .
• Do not use this medicine on irritated skin or on any area that is infected or reddened. Also, do not use this medicine if you are a diabetic or if you have poor blood circulation .
• Do not use this medicine on warts with hair growing from them or on warts on the face, in or on the genital (sex) organs, or inside the nose or mouth. Also do not use on moles or birthmarks . To do so may cause severe irritation.
• Avoid breathing in the vapors from the medicine.
• Wash the area to be treated and dry thoroughly. Warts may be soaked in warm water for 5 minutes before drying.
• Apply the medicine one drop at a time to completely cover each wart, corn, or callus. Let dry.
• For warts—Repeat one or two times a day as needed for up to 12 weeks, or as directed by your doctor, until wart is removed.
• For corns and calluses—Repeat one or two times a day as needed for up to 14 days, or as directed by your doctor, until the corn or callus is removed.
• Corns and calluses may be soaked in warm water for 5 minutes to help in their removal.
• If discomfort gets worse during treatment or continues after treatment, or if the wart spreads, check with your doctor.

Unless your hands are being treated, wash them immediately after applying this medicine to remove any medicine that may be on them.

Dosing—The dose of salicylic acid will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of salicylic acid. If your dose is different, do not change it unless your doctor tells you to do so.

• For cream dosage form:
  • For corns and calluses:
    • Adults and children—Use the 2 to 10% cream as needed. Use the 25 to 60% cream one time every three to five days.
• For gel dosage form:
  • For acne:
    • Adults and children—Use the 0.5 to 5% gel one time a day.
  • For psoriasis:
    • Adults and children—Use the 5% gel one time a day.
  • For common warts:
    • Adults and children—Use the 5 to 26% gel one time a day.
• For lotion dosage form:
  • For acne:
    • Adults and children—Use the 1 to 2% lotion one to three times a day.
  • For dandruff and antiseborrhic dermatitis of the scalp:
    • Adults and children—Use the 1.8 to 2% lotion on the scalp one or two times a day.
• For ointment dosage form:
  • For acne:
    • Adults and children—Use the 3 to 6% ointment as needed.
  • For psoriasis and seborrheic dermatitis:
    • Adults and children—Use the 3 to 10% ointment as needed.
  • For common warts:
    • Adults and children—Use the 3 to 10% ointment as needed. Use the 25 to 60% ointment one time every three to five days.
• For pads dosage form:
  • For acne:
    • Adults and children—Use one to three times a day.
• For plaster dosage form:
  • For corns, calluses, common warts, or plantar warts:
    • Adults and children—Use one time a day or one time every other day.
• For shampoo dosage form:
  • For dandruff or seborrheic dermatitis of the scalp:
    • Adults and children—Use on the scalp one or two times a week.
• For soap dosage form:
  • For acne:
    • Adults and children—Use as needed.
• For topical solution dosage form:
  • For acne:
    • Adults and children—Use the 0.5 to 2% topical solution one to three times a day.
  • For common warts and plantar warts:
    • Adults and children—Use the 5 to 27% topical solution one or two times a day.
  • For corns and calluses:
    • Adults and children—Use the 12 to 27% topical solution one or two times a day.

Missed dose—If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Keep the medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

When using salicylic acid, do not use any of the following preparations on the same affected area as this medicine , unless otherwise directed by your doctor:

• Abrasive soaps or cleansers
• Alcohol-containing preparations
• Any other topical acne preparation or preparation containing a peeling agent (for example, benzoyl peroxide, resorcinol, sulfur, or tretinoin [vitamin A acid])
• Cosmetics or soaps that dry the skin
• Medicated cosmetics
• Other topical medicine for the skin

To use any of the above preparations on the same affected area as salicylic acid may cause severe irritation of the skin.

Check with your doctor right away if you have nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy hyperpnea, diarrhea, and psychic disturbances. These could be symptoms of a serious condition called salicylate toxicity, especially in children under 12 years of age and patients with kidney or liver problems.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Other side effects may occur that usually do not need medical attention. However, check with your doctor if any of the following side effects continue or are bothersome:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your health care professional.

Revised: 01/19/2005

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