{"adverse_reactions":["6 ADVERSE REACTIONS Although rare, sodium sulfacetamide may cause local irritation."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours. The exact mode of action of sulfur in the treatment of acne is unknown, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids."],"contraindications":["4 CONTRAINDICATIONS Prascion™ TS is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Prascion™ TS is not to be used by patients with kidney disease."],"description":["11 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 gram of Prascion™ TS (sodium sulfacetamide 10% and sulfur 5%) Topical Suspension contains 100 mg of Sodium Sulfacetamide USP and 50 mg of Sulfur USP in a suspension containing: water, emulsifying wax, mineral oil, propylene glycol, sorbitol, cetyl alcohol, ceteareth-20, stearyl alcohol, dimethicone, cetyl palmitate, disodium EDTA, sodium thiosulfate, monobasic sodium phosphate, and fragrance."],"dosage_and_administration":["2 DOSAGE & ADMINISTRATION Cleanse affected areas. Apply a thin film of Prascion™ TS to affected areas 1 to 3 times daily, or as directed by your physician."],"effective_time":"20110202","how_supplied":["16 HOW SUPPLIED Prascion™ TS (sodium sulfacetamide 10% and sulfur 5%) Topical Suspension is available in a 30 g tube (NDC 66993-919-31). Store at 15°-25°C (59°-77°F). Manufactured For: Prasco Laboratories Cincinnati, OH 45249 USA Iss. 01/07 P6056.00."],"id":"29a64fcb-d5c5-4427-87e5-b7fcb77e52b1","indications_and_usage":["1 INDICATIONS & USAGE Prascion™ TS is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis."],"information_for_patients":["17 INFORMATION FOR PATIENTS Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops, discontinue use and consult your physician. 1 CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY Long-term studies in animals have not been performed to evaluate carcinogenic potential. 1 PREGNANCY Category C – Animal reproduction studies have not been conducted with Prascion™ TS. It is also not known whether Prascion™ TS can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Prascion™ TS should be given to a pregnant woman only if clearly needed. 3 NURSING MOTHERS It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Prascion™ TS. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Prascion™ TS is administered to a nursing woman. 4 PEDIATRIC USE Safety and effectiveness in children under the age of 12 have not been established."],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 29a64fcb-figure-01 29a64fcb-figure-02"],"precautions":["PRECAUTIONS General – If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility."],"set_id":"97cbac0d-fc70-4033-b4fe-5eef49b6961b","spl_product_data_elements":["Prascion TS sodium sulfacetamide and sulfur SULFACETAMIDE SODIUM SULFACETAMIDE SULFUR SULFUR WATER MINERAL OIL PROPYLENE GLYCOL SORBITOL CETYL ALCOHOL STEARYL ALCOHOL SODIUM THIOSULFATE"],"version":"1","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 . Keep away from eyes. Keep out of reach of children. Keep tube tightly closed."]}