{"adverse_reactions":["ADVERSE REACTIONS Reports of irritation and hypersensitivity to sulfacetamide sodium are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sulfacetamide sodium, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome has been reported. (See WARNINGS )"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies for carcinogenic potential have not been performed on Ovace® to date. Studies on reproduction and fertility also have not been performed. One author detected chromosomal nondisjunction in the yeast, Saccharomyces cerevisiae, following application of sulfacetamide sodium. The significance of this finding to the topical use of sulfacetamide sodium in the human is unknown."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Sulfacetamide sodium exerts a bacteriostatic effect against sulfonamide sensitive Gram-positive and Gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections. It acts by restricting the synthesis of folic acid required by bacteria for growth, by its competition with para-aminobenzoic acid. There are no clinical data available on the degree and rate of systematic absorption of Ovace® when applied to the skin or scalp. However, significant absorption of sulfacetamide sodium through the skin has been reported. The following in vitro data are available but their clinical significance is unknown. Organisms which show susceptibility to sulfacetamide sodium are: Streptococci , Staphylococci , E. coli , Klebsiella pneumoniae , Pseudomonas pyocyanea , Salmonella species , Proteus vulgaris , Nocardia and Actinomyces ."],"contraindications":["CONTRAINDICATIONS Ovace® is contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of the product."],"description":["DESCRIPTION Each gram of Ovace® Cream contains 100 mg of sodium sulfacetamide USP in a vehicle consisting of purified water, glycerin, mineral oil, cetearyl alcohol/ceteareth 20, cetyl alcohol, glyceryl stearate, PEG-100 stearate, phenoxyethanol, dimethicone, methylparaben, disodium EDTA, sodium thiosulfate, quaternium-26 and propylene glycol, and propylparaben. Each gram of Ovace® Gel contains 100 mg of sodium sulfacetamide USP in a vehicle consisting of purified water, glycerin, xanthan gum, methylparaben, disodium EDTA, sodium thiosulfate, quaternium-26 and propylene glycol, and lactic acid. Sulfacetamide sodium is C 8 H 9 N 2 NaO 3 S.H 2 O with molecular weight of 254.24. Chemically, it is Acetamide N-[4-aminophenyl)sulfonyl]-, monosodium salt, monohydrate, with the following structural formula: Sulfacetamide sodium is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform, and in ether. Sodium_sulfacetamide_formula"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Seborrheic dermatitis including seborrhea sicca – Ovace® . Apply to affected areas twice daily (morning and evening), or as directed by your physician. Avoid contact with eyes or mucous membranes. Repeat application as described for eight to ten days. As the condition subsides, the interval between applications may be lengthened. Applications once or twice weekly or every other week may prevent reoccurrence. Should the condition recur after stopping therapy, the application of Ovace® should be reinitiated as at the beginning of treatment. Secondary Cutaneous Bacterial Infections – Apply to affected areas twice daily for eight to ten days. Occasionally, a slight yellowish discoloration may occur when an excessive amount of the product is used and comes in contact with white fabrics. This discoloration, however, presents no problem a, as it is readily removed by ordinary laundering without bleaches."],"drug_interactions":["Drug Interactions: Ovace® is incompatible with silver preparations."],"effective_time":"20100120","how_supplied":["HOW SUPPLIED Ovace ® Cream is available in 30 gram (NDC 13548-043-30) and 60 gram (NDC 13548-043-60) tubes. Ovace® Gel is available in 30 gram (NDC 13548-042-30) and 60gram (NDC 13548-042-60) tubes."],"id":"69463992-aba6-4863-8647-9fcc6c28d0d9","indications_and_usage":["INDICATION AND USAGE Ovace® is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sica (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides."],"information_for_patients":["Information For Patients: Patients should discontinue Ovace® if the condition becomes worse, or if a rash develops in the area being treated or elsewhere. Ovace® also should be discontinued promptly and the physician notified if any arthritis, fever of sores in the mouth develop."],"nursing_mothers":["Nursing mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, cautions should be exercised when Ovace® is administered to a nursing woman."],"openfda":{},"overdosage":["OVERDOSAGE The oral LD 50 for sulfacetamide in mice is 16.5 g/kg. The LD 50 for topical administration of sulfacetamide has not been determined. Oral overdosage may cause nausea and vomiting. Large oral overdosage may cause hematuria, crystalluria, and renal shutdown due to the precipitation of sulfa crystals in the renal tubules and the urinary tract. For treatment, contact local Poison Control Center."],"package_label_principal_display_panel":["Ovace® Cream Principal Display Panel NDC 13548-043-30 Rx ONLY OVACE ® (SODIM SULFACETAMIDE 10%) CREAM 30 g CORIA TM LABORATORIES, LTD. Ovace_CRM_30_tube Ovace_CRM_30_CTN","Ovace® Gel Principal Display Panel NDC 13548-042-30 RX ONLY OVACE ® (SODIM SULFACETAMIDE 10%) GEL 30 g CORIA TM LABORATORIES, LTD. Ovace_GEL_30_tube Ovace_GEL_30_CTN"],"pediatric_use":["Pediatric use: Safety and effectiveness in children under the age of 12 years have not been established."],"precautions":["PRECAUTIONS For external use only General: Nonsusceptible organisms, including fungi, may proliferate with the use of this preparation. Hypersensitivity reactions may recur when a sulfonamide is readministrated, irrespective of the route of administration, and cross hypersensitivity between different sulfonamides may occur. If Ovace® produces signs of hypersensitivity or other untoward reactions, discontinue use of the preparation. Systemic absorption of sulfonamides is greater following application to large, infected, abraded, denuded, or severely burned areas. Under these circumstances, potentially any of the adverse effects produced by the systemic administration of these agents could occur and appropriate observations and laboratory determinations should be performed."],"pregnancy":["Pregnancy Category C: Animal reproduction studies have not been conducted with Ovace® . It also is not known whether Ovace® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Ovace® should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus."],"set_id":"02ce5033-d51e-4de4-9026-98433f45622d","spl_product_data_elements":["Ovace Sodium Sulfacetamide SULFACETAMIDE SODIUM SULFACETAMIDE WATER GLYCERIN XANTHAN GUM METHYLPARABEN EDETATE DISODIUM SODIUM THIOSULFATE PROPYLENE GLYCOL LACTIC ACID Ovace Sodium Sulfacetamide SULFACETAMIDE SODIUM SULFACETAMIDE WATER GLYCERIN MINERAL OIL CETYL ALCOHOL GLYCERYL MONOSTEARATE PHENOXYETHANOL DIMETHICONE METHYLPARABEN EDETATE DISODIUM SODIUM THIOSULFATE PROPYLENE GLYCOL PROPYLPARABEN CETOSTEARYL ALCOHOL"],"spl_unclassified_section":["RX ONLY OVACE ® (Sodium Sulfacetamide 10%) Cream OVACE ® (Sodium Sulfacetamide 10%) Gel FOR DERMATOLOGICAL USE ONLY. NOT FOR OPHTHALMIC USE.","Pharmacology: Ovace® has a bacteriostatic effect against Gram-positive and Gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections.","Marketed by CORIA LABORATORIES, LTD. Fort Worth, TX 76107 Manufactured by: DPT LABORATORIES, LTD. San Antonio, TX 78215 REORDER N0. Ovace® Cream 13548-043-30 (30 g tube) 13548-043-60 (60 g tube) Ovace® Gel 13548-042-30 (30 g tube) 13548-042-60 (60 g tube) 128315-1005"],"storage_and_handling":["Store at controlled room temperature 68 o – 77 o F (20 o – 25 o C). Do not freeze."],"version":"2","warnings":["WARNINGS Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sulfacetamide sodium topically. Cases of drug-inducted systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome. Keep out of the reach of children."]}