Precipitated Sulpher + Salicylic Acid

Salicylic acid and sulfur combination is used to treat acne and other skin disorders and dandruff and other scalp disorders, such as seborrheic dermatitis.

Salicylic acid is a potent keratolytic with mild antiseptic action when applied topically. Sulfur topical is a scabicide and keratolytic agent.

The mechanism of action when these two ingredients are combined, may be a synergistic keratolytic effect. The mechanism of action of salicylic acid in the treatment of acne may also include anti-inflammatory activity.

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

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For acne or oily skin-

Bar dosage form:

• Adults and children: Use on the affected skin two or three times a day.

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-

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.

Administration

Use salicylic acid and sulfur 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 salicylic acid and sulfur, wash your hands to remove any medicine that may be on them. Keep salicylic acid and sulfur 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 salicylic acid and sulfur 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 salicylic acid and sulfur to wash the face and other affected areas. Then rinse thoroughly and pat dry.

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Hyppersensitivity.

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: Skin irritation not present before use of salicylic acid and sulfur

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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

Breast Feeding: There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

When using salicylic acid and sulfur combination medicine, do not use any of the following preparations on the same affected area as salicylic acid and sulfur, 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 salicylic acid and sulfur . 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 salicylic acid and sulfur) may lead to overdose. If you have any questions about this, check with your health care professional.

Local Antipruritic, Other scalp preparations.

Pediatric: 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.

Geriatric: 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.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed.