Although rare, sensitivity to sodium sulfacetaminde 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. Keep away from eyes.
KEEP OUT OF REACH OF CHILDREN. Keep container tightly closed.
There is currently no manufacturer warning information available for this drug.
Rosula™ Cleansing Cloths are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:
Each cloth of Rosula™ Cleansing Cloths is coated with a cleanser-based formulation. Each gram of this cleanser-based formulation contains 100 mg of Sodium Sulfacetamide and 50 mg of Sulfur. The cleanser base consists of: Butylated hydroxytoluene, Disodium EDTA, Disodium laureth sulfosuccinate and Disodium lauryl sulfoacetate, Emulsifying wax, Hydrochloric acid, Methyl paraben, Mineral oil, PPG-hydroxyethyl coco isostearamide, Propyl paraben, Purified water, Sodium cocoyl isethionate and Sodium thiosulfate.
