SALICYLICACID AND SULFUR (Topical)

Some commonly used brand names are:

In the U.S.?

• Essential Care Creamy Dandruff Shampoo
• Essential Care Maximum Strength Dandruff Shampoo
• Essential Care Medicated Dandruff Wash
• Meted
• Pernox (Lemon)
• Pernox (Regular)
• Pernox Lathering Abradant Scrub Cleanser (Fresh Scent)
• Sebex
• Sebulex (Regular)
• Sebulex (with Conditioners)

In Canada?

• Meted
• Pernox (Lemon)
• Pernox (Regular)
• SAStid Soap
• Sebulex

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

Category

• Antiacne agent, topical
• Antiseborrheic
• Keratolytic, topical

Description

Salicylicacid and sulfur (sal-i-SILL-ik AS-idand SUL-fur) combination is used to treat acne and otherskin disorders and dandruff and other scalp disorders, such as seborrheicdermatitis.

This medicine is available without a prescription; however, your doctormay have special instructions on the proper use of this medicine for yourmedical condition.

Salicylic acid and sulfur combination is available in the following dosageforms:

Topical
• Bar (U.S. and Canada)
• Cleansing lotion (U.S. and Canada)
• Shampoo (U.S. and Canada)

Before Using This Medicine

If you are using this medicinewithout a prescription, carefully read and follow any precautions on the label.For salicylic acid and sulfur combination, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to salicylic acid or sulfur. Also tell your health careprofessional if you are allergic to any other substances, such as preservativesor dyes.

Pregnancy?Salicylic acid and sulfur combination has not beenstudied in pregnant women. However, for the individual medicines:

• Salicylic acid?Salicylic acid maybe absorbed through the mother's skin. Studies with topical salicylic acidhave not been done in humans. However, studies in animals have shown thatsalicylic acid causes birth defects when given orally in doses about six timesthe highest dose recommended for topical use in humans.
• Sulfur?Topical sulfur has not beenshown to cause birth defects or other problems in humans.

Before using this medicine, make sure your doctor knows if you are pregnantor if you may become pregnant.

Breast-feeding?Salicylic acid may be absorbed through the mother'sskin. However, topical salicylic acid and sulfur combination has not beenreported to cause problems in nursing babies.

Children?Young children may be at increased risk of unwantedeffects because of increased absorption of salicylic acid through the skin.Products containing salicylic acid should not be applied to large areas ofthe body or used for long periods of time in infants and children.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information comparing useof salicylic acid and sulfur combination in the elderly with use in otherage groups.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are using any other topical prescription or nonprescription(over-the-counter [OTC]) medicine that is to be applied to the same area ofthe skin.

Proper Use of This Medicine

Use this medicine only as directed. Do not use more of it and do notuse it more often than recommended on the label, unless otherwise directedby your doctor.

Immediately after using this medicine, wash your hands to remove any medicinethat may be on them.

Keep this medicine away from the eyes. If youshould accidentally get some in your eyes, flush them thoroughly with water.

To use the skin cleansing lotion:

• After wetting the skin, apply this medicine with your fingertipsor a wet sponge and rub in gently to work up a lather. Then rinse thoroughlyand pat dry.

To use the shampoo or bar as a shampoo:

• Wet the hair and scalp with lukewarm water. Then apply enough medicineto work up a lather and rub into the scalp. Continue rubbing the lather intothe scalp for several minutes or allow it to remain on the scalp for about5 minutes, depending on the product being used, then rinse. Apply the medicineagain and rinse thoroughly.

To use the bar as a soap:

• After wetting the skin, use this medicine to wash the face and otheraffected areas. Then rinse thoroughly and pat dry.

Dosing?The dose of salicylic acid and sulfur combinationwill be different for different patients. Follow yourdoctor's orders or the directions on the label. The following informationincludes only the average doses of salicylic acid and sulfur combination. If your dose is different, do not change it unlessyour doctor tells you to do so.

• For acne or oily skin:
  • For bar dosage form:
    • Adults and children?Use on the affected skin two or three timesa day.
  • For cleansing lotion dosage form:
    • Adults and children?Use on wet skin one to three times a day.Rub lather into skin for one minute then rinse.
• For dandruff and seborrheic dermatitis of the scalp:
  • For bar and shampoo dosage forms:
    • Adults and children?Use on the scalp once a day at least twotimes a week or as directed by doctor. May be used each day if needed.

Missed dose?If you miss a dose of this medicine, apply or useit 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 surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

When using salicylic acid and sulfur combination medicine, donot use any of the following preparations on the same affected area as thismedicine, unless otherwise directed by your doctor:

• Abrasive soaps or cleansers
• Alcohol-containing preparations
• Any other topical acne preparation or preparation containing a peelingagent (for example, benzoyl peroxide, resorcinol, or tretinoin [vitamin Aacid])
• 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 salicylicacid and sulfur combination medicine may cause severe irritation of the skin.

Do not use any topical mercury-containing preparation,such as ammoniated mercury ointment, on the same affected area as this medicine. To do so may cause a foul odor, may be irritating to the skin, andmay stain the skin black. If you have any questions about this, check withyour health care professional.

Taking large doses of aspirin or other salicylates (including diflunisal)while using topical salicylic acid (contained in this medicine) may lead tooverdose. If you have any questions about this, check with your health careprofessional.

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 mayneed medical attention.

Check with your doctor as soon as possible if the following side effectoccurs:

Skin irritation not present before use of this medicine

Other side effects may occurthat usually do not need medical attention. However, check with your healthcare professional if the following side effects continue or are bothersome:

Redness and peeling of skin (may occur after a few days); unusual dryness of skin

Otherside effects not listed above may also occur in some patients. If you noticeany other effects, check with your health care professional.