OVACE® (sodium sulfacetamide)

The OVACE® (sodium sulfacetamide) product family (OVACE® Plus Foam, OVACE® Plus Wash Cleansing Gel, OVACE® Plus Shampoo, OVACE® Plus Cream, OVACE® Plus Lotion) is intended as a topical application for patients with the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff).

OVACE® Plus Foam, OVACE® Plus Wash Cleansing Gel, OVACE® Plus Cream, and OVACE® Plus Lotion are also indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides. Sodium sulfacetamide is a sulfonamide with antibacterial activity.

With the wide range of steroid-free OVACE® product formulations your physician can choose from, there might be one that’s just right for you.

Unlike certain other products, the OVACE® product family does not contain sulfur. This can provide physicians with greater flexibility for treating seborrheic dermatitis (SD) due to the fact that there is a small percentage of the population that is allergic or sensitive to sulfur. OVACE® products are contraindicated in patients who have known or suspected hypersensitivity to sulfonamides or to any of the ingredients of the products.

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. The OVACE® brand products 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.



OVACE® Plus Wash Cleansing Gel

OVACE® Plus Wash

OVACE® Plus Wash (sodium sulfacetamide 10%) Cleansing Gel

OVACE® Plus Wash Cleansing Gel is intended as a topical application for patients with the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff).

OVACE® Plus Wash Cleansing Gel is also indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides. Sodium sulfacetamide is a sulfonamide with antibacterial activity.

OVACE® Plus Wash Cleansing Gel is an effective solution for cleansing the face and body. It is a sulfur-free, clear facial wash with a refreshing scent that is ideal for patients who are sensitive to sulfur. Usage involves twice-daily application that follows a normal cleansing routine. OVACE® Plus Wash Cleansing Gel is available in a large 12-ounce size, which may help make the product more affordable for some patients.

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

OVACE® Plus Wash Cleansing Gel is also indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.

Sodium sulfacetamide is a sulfonamide with antibacterial activity.

Important Safety Information

CONTRAINDICATIONS: OVACE® Plus Wash Cleansing Gel is contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of this product. OVACE® Plus Wash Cleansing Gel 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 Wash Cleansing Gel 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 Wash Cleansing Gel is for external use only. Patients should be instructed to avoid contact with eyes, lips, and mucous membranes. Long-term animal studies to assess 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.


For additional information, click here for full Prescribing Information.



Ovace® Plus Shampoo

OVACE® Plus Shampoo

OVACE® Plus (sodium sulfacetamide 10%) Shampoo

OVACE® Plus Shampoo is intended as a topical application for patients with the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff).

It is a practical formulation for washing the hair and scalp. This sulfur-free shampoo has a refreshing scent that patients will appreciate. Recommended use of OVACE® Plus Shampoo is twice weekly, a schedule that can fit well into most patients’ routines, and can help encourage proper use. It is important to note that SD is basically dandruff of the face and body, and is often seen in men with beards, for whom OVACE® Plus Shampoo might be especially beneficial.

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.

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 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.



For additional information, click here for full Prescribing Information.



Ovace® Plus Lotion

OVACE® Plus Lotion

OVACE® Plus (sodium sulfacetamide 9.8%) Lotion

OVACE® Plus Lotion is intended as a topical application for patients with the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca.

It is also indicated for treating secondary bacterial infections of the skin due to organisms susceptible to sulfonamides and who require application over larger areas of the body. OVACE® Plus Lotion is a refreshing, scented, sulfur-free solution that patients will appreciate. Recommended use of OVACE® Plus Lotion is twice daily (morning and evening), or as directed by a physician.

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

OVACE® Plus Lotion is also indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.

Sodium sulfacetamide is a sulfonamide with antibacterial activity.

Important Safety Information

CONTRAINDICATIONS: OVACE® Plus Lotion is contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of this product. OVACE® Plus Lotion 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 Lotion 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 Lotion is for external use only. Patients should be instructed to avoid contact with eyes, lips, and mucous membranes.

Long-term animal studies to assess 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.



For additional information, click here for full Prescribing Information.



OVACE® Plus Cream

OVACE® Plus Cream (sodium sulfacetamide)

OVACE® Plus (sodium sulfacetamide 10%) Cream

OVACE® Plus Cream is intended as a topical application for patients with the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca. And it is also indicated for secondary bacterial infections of the skin due to organisms susceptible to sulfonamides. It is easy to concentrate on affected areas of the body and control application around delicate areas. OVACE® Plus Cream is a refreshing scented sulfur-free solution that patients will appreciate. Recommended use of OVACE® Plus Cream is twice daily (morning and evening), or as directed by a physician. Avoid contact with eyes or mucous membranes.

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

OVACE® Plus Cream is also indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.

Sodium sulfacetamide is a sulfonamide with antibacterial activity.

Important Safety Information

CONTRAINDICATIONS: OVACE® Plus Cream is contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of this product. OVACE® Plus Cream 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 Cream 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 Cream is for external use only. Patients should be instructed to avoid contact with eyes, lips, and mucous membranes.

Long-term animal studies to assess 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.



For additional information, click here for full Prescribing Information.



OVACE® Plus Foam

ovace plus foam

OVACE® Plus (sodium sulfacetamide 10%) Foam

OVACE® Plus Foam is intended as a topical application for patients with the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca. And it is also indicated for secondary bacterial infections of the skin due to organisms susceptible to sulfonamides. It is easy to concentrate on affected areas of the body and control application around delicate areas. OVACE® Plus Foam is a refreshing scented sulfur-free solution that patients will appreciate. Recommended use of OVACE® Plus Foam is twice daily (morning and evening), or as directed by a physician. Avoid contact with eyes or mucous membranes.

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

OVACE® Plus Foam is also indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.

Sodium sulfacetamide is a sulfonamide with antibacterial activity.

Important Safety Information

CONTRAINDICATIONS: OVACE® Plus Foam is contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of this product. OVACE® Plus Foam 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 Foam 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 Foam is for external use only. Patients should be instructed to avoid contact with eyes, lips, and mucous membranes.

Long-term animal studies to assess 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.



For additional information, click here for full Prescribing Information.