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|Sebutone Topical

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SALICYLIC ACID, SULFUR, AND COAL TAR (Topical)

Some commonly used brand names are:

In the U.S.—

Sebex-T Tar Shampoo
Sebutone
Vanseb-T

In Canada—

Sebutone

Description

Salicylic acid, sulfur, (sal-i-SILL-ik AS-id, SUL-fur) and coal tar combination is used to treat dandruff, seborrheic dermatitis, and psoriasis of the scalp.

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, sulfur, and coal tar combination is available in the following dosage forms:

Topical
Cream shampoo (U.S.)
Lotion 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, sulfur, and coal tar combination, the following should be considered:

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

Pregnancy—Salicylic acid, sulfur, and coal tar 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 6 times the highest dose recommended for topical use in humans.
Sulfur —Sulfur has not been shown to cause birth defects or other problems in humans.
Coal tar —Studies with coal tar on effects in pregnancy have not been done in either humans or animals.

Breast-feeding—Salicylic acid may be absorbed through the mother"s skin. However, topical salicylic acid, sulfur, and coal tar 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. Medicines 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, sulfur, and coal tar combination medicine 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 it more often than recommended on the label, unless otherwise directed by your doctor.

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

Before using this medicine, wet the hair and scalp with lukewarm water. Then apply a generous amount to the scalp and work up a rich lather. Rub the lather into the scalp for 5 minutes, then rinse. Apply the medicine again and rinse thoroughly.

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

Dosing—The dose of salicylic acid, sulfur, and coal tar 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, sulfur, and coal tar combination. If your dose is different, do not change it unless your doctor tells you to do so.

For dandruff, seborrheic dermatitis, and psoriasis of the scalp:
- For cream shampoo and lotion shampoo dosage forms:
  - Adults and children—Use on the scalp one or two times a week.

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

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.

This medicine may temporarily discolor blond, bleached, or tinted hair.

Side Effects of This Medicine

In animal studies, coal tar (contained in this combination medicine) has been shown to increase the chance of skin cancer.

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

Revised: 07/26/1993

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