SALICYLICACID, 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

Category

• Antipsoriatic, topical
• Antiseborrheic
• Keratolytic, topical

Description

Salicylicacid, 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 doctormay have special instructions on the proper use of this medicine for yourmedical condition.

Salicylic acid, sulfur, and coal tar combination is available in the followingdosage forms:

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

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

Pregnancy?Salicylic acid, sulfur, and coal tar combinationhas not been studied 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 6 timesthe highest dose recommended for topical use in humans.
• Sulfur?Sulfur has not been shownto cause birth defects or other problems in humans.
• Coal tar?Studies with coal tar oneffects in pregnancy have not been done in either humans or animals.

Breast-feeding?Salicylic acid may be absorbed through the mother'sskin. However, topical salicylic acid, sulfur, and coal tar combination hasnot been reported 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.Medicines 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, sulfur, and coal tar combination medicine in the elderlywith use in other age 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 it more often than recommendedon the label, unless otherwise directed by your doctor.

Keep this medicine away from the eyes. If youshould 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 thelather into the scalp for 5 minutes, then rinse. Apply the medicine againand rinse thoroughly.

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

Dosing?The dose of salicylic acid, sulfur, and coaltar combination will be different for different patients. Follow your doctor's orders or the directions on the label. The followinginformation includes only the average doses of salicylic acid, sulfur, andcoal tar combination. If your dose is different, do notchange it unless your doctor tells you to do so.

• For dandruff, seborrheic dermatitis, and psoriasis of the scalp:
  • For cream shampoo and lotion shampoodosage 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 assoon as possible. However, if it is almost time for your next dose, skip themissed 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

Do not use any topical mercury-containing preparation, suchas 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.

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) hasbeen 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 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 not listed above may also occur insome patients. If you notice any other effects, check with your health careprofessional.