sulfacetamide sodium

FDA Drug Profile — Sulfacetamide Sodium, Klaron

sulfacetamide sodium is listed in the FDA National Drug Code directory with 7 NDC codes, marketed under brand names including Sulfacetamide Sodium, Klaron. Available dosage forms: solution/ drops, lotion.

Drug Details

Generic Name
sulfacetamide sodium
Brand Names
Sulfacetamide Sodium, Klaron
Application Number
ANDA040066
Sponsor
Asclemed USA, Inc.
NDC Codes
7
Dosage Forms
SOLUTION/ DROPS, LOTION
Routes
OPHTHALMIC, TOPICAL
Active Ingredients
SULFACETAMIDE SODIUM

Indications and Usage

INDICATIONS: Sodium Sulfacetamide 9% - Sulfur 4% Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Warnings

WARNINGS: Although rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved. For external use only. Avoid contact with eyes. KEEP OUT OF REACH OF CHILDREN. Keep bottle tightly closed.