{"adverse_reactions":["ADVERSE REACTIONS Contact sensitization reactions are associated with the use of topical benzoyl peroxide and sulfur products and may be expected to occur in 10 to 25 of 1000 patients. The most frequent adverse reactions associated with benzoyl peroxide and sulfur use are excessive erythema and peeling which may be expected to occur in 5 of 100 patients. Excessive erythema and peeling most frequently appear during the initial phase of drug use and may normally be controlled by reducing frequency of use."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY The exact mode of action of benzoyl peroxide and sulfur in acne vulgaris is unknown but its antibacterial activity against Propionibacterium acnes is thought to be a major mode of action. Benzoyl peroxide and sulfur are believed to exert a beneficial effect because of their antimicrobial activity and their mild keratolytic action."],"contraindications":["CONTRAINDICATIONS NuOx gel is contraindicated in persons who have shown hypersensitivity to benzoyl peroxide, sulfur, or to any of the other ingredients in the products."],"description":["DESCRIPTION NuOx gel is a topical preparation containing Benzoyl Peroxide 6% and Sulfur 3% as the active ingredients. NuOx gel also contains: Allantoin, Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol, Carbomer, Citric Acid Disodium EDTA, Disodium Oleamido MEA Sulfoscuccinate, Glycerin, Purified Water and Sodium Citrate."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION It is recommended that therapy be initited with NuOx gel, by applying the medication to the affected areas once a day during the first week, and twice a day thereafter as tolerated. Frequency of use should be adjusted to obtain the desired clinical response. Gentle cleansing of the affected areas with a non-medicated soap prior to application of NuOx gel may be beneficial. Clinically visible improvement will normally occur by the third week of therapy. Continuing use of the drug is normally required to maintain a satisfactory clinical response."],"effective_time":"20120608","how_supplied":["HOW SUPPLIED NuOx gel is supplied in 43 g plastic tubes. NuOx gel NDC 54868-5947-0 NuOx gel should be stored at controlled room temperature, 15C-30C (59F-86F). WraSer Pharmaceuticals 121 Marketridge Dr. Ridgeland, MS 39157 Rev. 1209 Rx only Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146"],"id":"f1c37bf2-b5fe-442d-a44f-e4c9e4900899","indications_and_usage":["INDICATIONS AND USAGE NuOx gel is indicated In the treatment of acne vulgaris. See Dosage and Administration section for information on frequency and duration of drug use."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NuOx 43 gram NDC 54868-5947-0 NO LABEL AVAILABLE"],"precautions":["PRECUATIONS NuOx gel is for external use only, They should not be permitted to contact the eyes or mucosal membranes. If severe irritation develops, discontinue use and institute appropriate therapy. After reaction clears, treatment may often be resumed with less frequent application. Avoid contact with hair, fabrics or carpeting as benzoyl peroxide will cause bleaching. Long-term studies utilizing rats and mice have been performed to evaluate the carcinogenic potential of benzoyl peroxide. Benzoyl peroxide showed no carcinogenic activity in these studies. Pregnancy: Category C. Animal reproduction studies have not been conducted with NuOx gel. It is also not known whether NuOx gel can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. NuOx gel should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted In human milk, caution should be exercised when NuOx gel is administered to a nursing woman."],"set_id":"c78e880e-01ff-4fc2-ab19-4e58ff1227a8","spl_patient_package_insert":["NuOx Insert NuOxgel (benzoyl peroxide 6% and sulfur 3%) Rx onlyDescription: NuOx gel is a topical preparation containing benzoyl peroxide 6% and sulfur 3% as the active ingredients. NuQx gel also contains: Allantoin,Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol. Carbomer, Citric Acid, Disodium EDTA, Disodium Oleamido MEA Sulfoscuccinate,Glycerin, Purified Water and Sodium Citrate.Clinical Pharmacology: The exact mode of action of benzoyl peroxide and sulfur in acne vulgaris is unknown but its antibacterial activity against Propionibacterium acnes is thought to be a major mode of action. Benzoyl peroxide and sulfur are believed to exert a beneficial effect because of their antimicrobial activity and their mild keratolytic action. Indications and Usage: NuOx gel is indicated In the treatment of acne vulgaris. See Dosage and Administration section for information on frequency and duration of drug use.Contraindlcatlons: NuOx gel is contraindicated in persons who have shown hypersensitivity to benzoyl peroxide, sulfur, or to any of the other ingredients in the products.Precautions: NuOx gel is for external use only, They should not be permitted to contact the eyes or mucosal membranes. If severe irritation develops, discontinue use and institute appropriate therapy. After reaction clears, treatment may often be resumed with less frequent application. Avoid contact with hair, fabrics or carpeting as benzoyl peroxide will cause bleaching. Long-term studies utilizing rats and mice have been performed to evaluate the carcinogenic potential of benzoyl peroxide. Benzoyl peroxide showed no carcinogenic activity in these studies. Pregnancy: Category C. Animal reproduction studies have not been conducted with NuOx gel. It is also not known whether NuOx gel can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. NuOx gel should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted In human milk, caution should be exercised when NuOx gel is administered to a nursing woman. Adverse Reactions: Contact sensitization reactions are associated with the use of topical benzoyl peroxide and sulfur products and may be expected to occur in 10 to 25 of 1000 patients. The most frequent adverse reactions associated with benzoyl peroxide and sulfur use are excessive erythema and peeling which may be expected to occur in 5 of 100 patients. Excessive erythema and peeling most frequently appear during the initial phase of drug use and may normally be controlled by reducing frequency of use. Dosage and Administration: It is recommended that therapy be initited with NuOx gel, by applying the medication to the affected areas once a day during the first week, and twice a day thereafter as tolerated. Frequency of use should be adjusted to obtain the desired clinical response.Gentle cleansing of the affected areas with a non-medicated soap prior to application of NuOx gel may be beneficial. Clinically visible improvement will normally occur by the third week of therapy. Continuing use of the drug is normally required to maintain a satisfactory clinical response. How Supplied: NuOx gel is supplied in 43 g plastic tubes. NuOx gel NDC 66992-170-01, NDC 66992-170-43 NuOx gel should be stored at controlled room temperature, 15C-30C (59F-86F). WraSer Pharmaceuticals 121 Marketridge Dr. Ridgeland, MS 39157 Rev. 1209 Rx only"],"spl_product_data_elements":["NuOx Acne Treatment Benzoyl Peroxide, Sulfur Benzoyl Peroxide Benzoyl Peroxide Sulfur Sulfur Allantoin Benzyl Alcohol water glycerin sodium citrate DISODIUM OLEAMIDO MEA-SULFOSUCCINATE"],"version":"1"}