sulfacetamide sodium
Drug Details
- Generic Name
- sulfacetamide sodium
- Brand Names
- Sulfacetamide Sodium, Klaron
- Application Number
- ANDA040066
- Sponsor
- Proficient Rx LP
- NDC Codes
- 7
- Dosage Forms
- SOLUTION/ DROPS, LOTION
- Routes
- OPHTHALMIC, TOPICAL
- Active Ingredients
- SULFACETAMIDE SODIUM
Indications and Usage
INDICATIONS: This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
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 REACH OF CHILDREN.