{"active_ingredient":["Active Ingredient Chlorhexidine gluconate 4% Solution"],"ask_doctor":["Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition."],"do_not_use":["Do not use if you are allergic to chlorhexidine gluconate or any other ingredients in contact with meninges in the genital area as a preoperative skin preparation of the head or face"],"dosage_and_administration":["Directions use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. Surgical hand scrub: wet hands and forearms under running water scrub for 3 minutes with about 5 mL of product and a wet brush, paying close attention to the nails, cuticles, and interdigital spaces a seperate nail cleaner may be used rinse thoroughly wash for an additional 3 minutes with 5 mL of product and rinse under running water dry thoroughly Healthcare personnel handwash: wet hands with water dispense about 5 mL of product in cupped hands and wash in a vigorous manner for about 15 seconds rinse and dry thoroughly Patient preoperative skin preparation: apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel repeat procedure for an additional 2 minutes and dry with a sterile towel Skin wound and general skin cleansing: thoroughly rinse the area to be cleaned with water apply the minimum amount of product necessary to cover the skin or wound area and wash gently rinse again thoroughly"],"effective_time":"20200320","id":"a14eef7a-91a7-0de9-e053-2995a90a66d6","inactive_ingredient":["Inactive ingredients cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol."],"indications_and_usage":["Uses surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care healthcare personnel handwash: helps reduce bacteria that potentially can cause disease patient preoperative skin preparation: for the preparation of the patient's skin prior to surgery skin wound and general skin cleansing"],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{},"other_safety_information":["Warning: This product contains a chemical (cocamide DEA) known to the State of California to cause cancer. Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products. Rinse completely and use only non-chlorine detergents. *This product is not manufactured or distributed by Mölnlycke Healthcare, owner of the registered trademark Hibiclens®."],"package_label_principal_display_panel":["Principal Display NDC 37205-595-32 LEADER Compare to Hibiclens active ingredient Antiseptic Skin Cleanser (CHLORHEXIDINE GLUCONATE 4% SOLUTION) ANTISEPTIC / ANTIMICROBIAL SKIN CLEANSER FOR EXTERNAL USE ONLY DYE FREE 8 FL OZ (237 mL) TAMPER EVIDENT: DO NOT USE IF shrink seal neckband is broken or missing 4LEAD08 PDP 4LEAD08 DF1 4LEAD08 DF2 4LEAD08 DF3"],"purpose":["Purpose Antiseptic"],"questions":["Questions or comments? call 1-800-587-3721 , Monday through Friday 8:00 AM to 4:30 PM CST"],"recent_major_changes":["Indications and Usage Dosage and Administration Uses Directions"],"set_id":"5577ecbb-cf2c-45e1-a0fb-17df0417eea5","spl_product_data_elements":["ANTISEPTIC SKIN CLEANSER CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE CHLORHEXIDINE COCO DIETHANOLAMIDE HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) ISOPROPYL ALCOHOL WATER TRIDECYL ALCOHOL GLUCONOLACTONE PEG-75 LANOLIN"],"storage_and_handling":["Other information store at 20-25ºC (68-77ºF) avoid excessive heat above 40ºC (104ºF)"],"version":"5","warnings":["Warnings For external use only Do not use if you are allergic to chlorhexidine gluconate or any other ingredients in contact with meninges in the genital area as a preoperative skin preparation of the head or face When using this product keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardrums if solution should contact these areas, rinse out promptly and thoroughly with water wounds which involve more than the superficial layers of the skin should not be routinely treated repeated general skin cleansing of large body areas should not be done except when the underlying condition makes it necessary to reduce the bacterial population of the skin Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardrums if solution should contact these areas, rinse out promptly and thoroughly with water wounds which involve more than the superficial layers of the skin should not be routinely treated repeated general skin cleansing of large body areas should not be done except when the underlying condition makes it necessary to reduce the bacterial population of the skin"]}