INDICATIONS: OVACE^® Plus Shampoo (sodium sulfacetamide) is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff).

Sodium sulfacetamide is a sulfonamide with antibacterial activity.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: OVACE Plus Shampoo is contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of this product. OVACE Plus Shampoo should not be used by patients with kidney disease.

WARNINGS: Serious hypersensitivity reactions, such as Stevens-Johnson syndrome, have been reported with sulfonamides, including topical sodium sulfacetamide. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide, including one case with a fatal outcome, have been reported. OVACE Plus Shampoo should be discontinued at the first signs of hypersensitivity, skin rash, or other reactions.

Topical sodium sulfacetamide should be kept out of the reach of children.

PRECAUTIONS: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

Non-susceptible organisms, including fungi, may proliferate with use of this preparation.

Although rare, sensitivity to sulfacetamide may occur. Patients who may be prone to hypersensitivity to topical sulfonamides should be carefully monitored. If the condition under treatment becomes worse, or irritation, signs of hypersensitivity, or other untoward reactions occur, this product should be discontinued and appropriate therapy instituted. Patients should be instructed to discontinue this product immediately and notify a physician if any arthritis, fever, or sores in the mouth occur.

Patients should be carefully monitored for local irritation or sensitization during long-term therapy. Systemic toxic reactions (e.g., agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice, and contact dermatitis) indicate sensitivity to sulfonamides. Hypersensitivity reactions may occur when a sulfonamide is readministered, regardless of the route of administration, and cross-reactivity between different sulfonamides may occur.

Particular caution should be employed if topical sulfacetamide is applied to large, infected, abraded, denuded or severely burned areas. As with systemic administration of sulfonamides, appropriate observations and laboratory determinations should be performed.

OVACE Plus Shampoo is for external use only. Patients should be instructed to avoid contact with eyes, lips, and mucous membranes.

Long-term animal studies to assess the carcinogenic potential of this product have not been performed.

There are no adequate and well-controlled studies of topical sodium sulfacetamide in pregnant women, and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman. This product should be given to a pregnant woman only if clearly needed, or when potential benefits outweigh potential hazards to the fetus.

It is not known whether sodium sulfacetamide is excreted in the human milk following topical use. Because many drugs are excreted in human milk, caution should be exercised in prescribing for nursing women.

Safety and effectiveness in pediatric patients under the age of 12 have not been established.

ADVERSE REACTIONS: Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported.

Please see full prescribing information.