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|Pernox

SALICYLIC ACID 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

Salicylic acid and sulfur (sal-i-SILL-ik AS-id and SUL-fur) combination is used to treat acne and other skin disorders and dandruff and other scalp disorders, such as seborrheic dermatitis.

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

Salicylic acid and sulfur combination is available in the following dosage forms:

• 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 medicine without 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 or allergic reaction to salicylic acid or sulfur. Also tell your health care professional if you are allergic to any other substances, such as preservatives or dyes.

Pregnancy—Salicylic acid and sulfur combination has not been studied in pregnant women. However, for the individual medicines:

• Salicylic acid —Salicylic acid may be absorbed through the mother"s skin. Studies with topical salicylic acid have not been done in humans. However, studies in animals have shown that salicylic acid causes birth defects when given orally in doses about six times the highest dose recommended for topical use in humans.
• Sulfur —Topical sulfur has not been shown to cause birth defects or other problems in humans.

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

Breast-feeding—Salicylic acid may be absorbed through the mother"s skin. However, topical salicylic acid and sulfur combination has not been reported to cause problems in nursing babies.

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

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of salicylic acid and sulfur combination in the elderly with use in other age groups.

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 topical prescription or nonprescription (over-the-counter [OTC]) medicine that is to be applied to the same area of the skin.

Proper Use of This Medicine

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

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

Keep this medicine away from the eyes . If you should 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 fingertips or a wet sponge and rub in gently to work up a lather. Then rinse thoroughly and pat dry.

To use the shampoo or bar as a shampoo:

• Wet the hair and scalp with lukewarm water. Then apply enough medicine to work up a lather and rub into the scalp. Continue rubbing the lather into the scalp for several minutes or allow it to remain on the scalp for about 5 minutes, depending on the product being used, then rinse. Apply the medicine again and rinse thoroughly.

To use the bar as a soap:

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

Dosing—The dose of salicylic acid and sulfur combination 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 and sulfur combination. If your dose is different, do not change it unless your 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 times a 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 two times 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 use 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 and sulfur combination medicine, 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, 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 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, and may stain the skin black. If you have any questions about this, check with your health care professional.

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

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 the following side effect occurs:

Skin irritation not present before use of this medicine

Other side effects may occur that usually do not need medical attention. However, check with your health care 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

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: 08/13/1998

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