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. 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.
INDICATIONS: Prascion FC Facial Cleansing Cloths are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Rx Only
DESCRIPTION: 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 Prascion® FC (sodium sulfacetamide USP 10% and sulfur USP 5%) Facial Cleansing Cloths is coated with a cleanser-based formulation. Each gram of this cleanser-based formulation contains 100 mg of sodium sulfacetamide USP and 50 mg of sulfur USP. The cleanser base consists of: butylated hydroxytoluene NF, cetyl alcohol NF, disodium oleamido MEA sulfosuccinate, edetate disodium USP, fragrance, glyceryl stearate/PEG-100 stearate, glycerin USP, methylparaben NF, propylparaben NF, purified water USP, sodium cocoyl isethionate, sodium lauryl sulfoacetate, sodium thiosulfate USP, stearyl alcohol NF.