Rosula Wash

Sulfacetamide sodium and sulfur are antibiotic that fight bacteria.

Sulfacetamide sodium and sulfur topical (for the skin) is a combination medicine used to treat acne, rosacea, and seborrheic dermatitis (a red, flaking skin rash).

Sulfacetamide sodium and sulfur topical may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to sulfa drugs or if you have kidney disease.

You should not use this medicine if you are allergic to sulfa drugs or if you have kidney disease.

To make sure sulfacetamide sodium and sulfur topical is safe for you, tell your doctor about all of your medical conditions.

It is not known whether sulfacetamide sodium and sulfur topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether this medicine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water. Do not use on sunburned, windburned, dry, chapped, irritated, or broken skin.

Avoid using other medications on the areas you treat with sulfacetamide sodium and sulfur topical unless your doctor tells you to.

It is not likely that other drugs you take orally or inject will have an effect on topically applied sulfacetamide sodium and sulfur. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Wash your hands before and after applying this medication.

Do not cover the treated skin area unless your doctor has told you to.

Use sulfacetamide sodium and sulfur topical regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours. The exact mode of action of sulfur in the treatment of acne is not known, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

Rosula™ Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Rosula™ Wash is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Rosula™ Wash is not to be used by patients with kidney disease.

It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Rosula™ Wash. However, small amounts of orally administered sulfonamides have been reported to be excreted in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Rosula™ Wash is administered to a nursing woman.

Rosula™ (Sodium Sulfacetamide 10% and Sulfur 4.5%) Wash is supplied in a 12 oz (340.2 g) bottle (NDC 75854-0105-12).For lot number and expiration date, see bottom of bottle.