OVACE Plus
Generic: SULFACETAMIDE SODIUM
Basic Information
Manufacturer
Mission Pharmacal Company
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
eca5fc5d-35d0-4803-990d-1f38f860c52a
Indications & Usage
INDICATIONS: This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff).
It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.
It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.
Warnings
WARNINGS: Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals.
Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically.
Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported.
In one of these cases, there was a fatal outcome.
KEEP OUT OF THE REACH OF CHILDREN.
Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically.
Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported.
In one of these cases, there was a fatal outcome.
KEEP OUT OF THE REACH OF CHILDREN.
Adverse Reactions
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 (see WARNINGS).
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 (see WARNINGS).