{"adverse_reactions":["ADVERSE REACTIONS In clinical trials there was one report of a possible contact sensitization which could not be confirmed. There were isolated reports of skin irritation, such as erythema and peeling."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Although the mechanism by which Akne-mycin acts in reducing the inflammatory lesions of acne vulgaris is unknown, it is presumably due to the antibiotic action of the drug."],"contraindications":["CONTRAINDICATIONS Akne-mycin is contraindicated in persons who have shown hypersensitivity to erythromycin or to any of the other listed ingredients."],"description":["DESCRIPTION Akne-mycin (erythromycin) topical ointment contains erythromycin which is produced from a strain of Streptomyces erythraeus . Each gram of Akne-mycin topical ointment contains 20 mg of erythromycin base in a vehicle consisting of mineral oil, petrolatum, paraffin, talc, titanium dioxide, trilaureth 4 phosphate, oleyl oleate, tricetareth 4 phosphate, cetostearyl alcohol and sorbitol. Akne-mycin marketed in the United States is not of the same composition as Akne-mycin marketed in Europe."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Akne-mycin should be applied to the affected area twice daily, morning and evening."],"effective_time":"20141117","how_supplied":["HOW SUPPLIED Akne-mycin is supplied in a 25 gram sealed tube. Store below 27°C (80°F)."],"id":"e4d1b280-d9cd-467b-af0a-1227bb087bbf","indications_and_usage":["INDICATIONS AND USAGE Akne-mycin is indicated for topical control of acne vulgaris."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 25 g Tube Carton Akne-mycin ® 2% (Erythromycin) NDC 13548-030-25 Rx ONLY FOR EXTERNAL USE ONLY TOPICAL OINTMENT FOR ACNE NET WT 25 g CORIA ® LABORATORIES, LTD. Principal Display Panel - 25 g Tube Carton"],"precautions":["PRECAUTIONS Akne-mycin is for topical use only and should be kept out of the eyes, nose and mouth. The use of antibiotic agents may be associated with the overgrowth of antibiotic resistant organisms. If this occurs, administration of the drug should be discontinued and appropriate measures taken."],"set_id":"720512c7-9ea4-40c8-b119-b39a3f9a448b","spl_product_data_elements":["Akne-mycin erythromycin erythromycin erythromycin mineral oil petrolatum paraffin talc titanium dioxide oleyl oleate cetostearyl alcohol sorbitol"],"spl_unclassified_section":["Rx ONLY 2% TOPICAL OINTMENT FOR ACNE FOR EXTERNAL USE ONLY","Marketed by: CORIA LABORATORIES, LTD. Fort Worth, Texas 76107 Reorder No. 13548-030-25 Manufactured by: DPT Laboratories Ltd. San Antonio, TX 78215 128312-1105"],"version":"4","warnings":["WARNINGS The safe use of Akne-mycin during pregnancy or lactation has not been established."]}