{"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 or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product in contact with meninges in the genital area"],"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. Healthcare personnel handwash: wet hands with water dispense about 5 mL of product into cupped hands and wash in a vigorous manner for about 15 seconds rinse and dry thoroughly Skin wound and general skin cleansing: throughly 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":"20260427","id":"50762eee-e13a-4d7f-e063-6294a90a777c","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 healthcare personnel handwash: helps reduce bacteria that potentially can cause disease 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":{"application_number":["NDA019125"],"brand_name":["ANTISEPTIC SKIN CLEANSER"],"generic_name":["CHLORHEXIDINE GLUCONATE"],"is_original_packager":[true],"manufacturer_name":["Xttrium Laboratories, Inc."],"package_ndc":["0116-0407-01"],"product_ndc":["0116-0407"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["TOPICAL"],"rxcui":["211365"],"spl_id":["50762eee-e13a-4d7f-e063-6294a90a777c"],"spl_set_id":["4a9eda34-d85c-4b66-e054-00144ff88e88"],"substance_name":["CHLORHEXIDINE GLUCONATE"],"unii":["MOR84MUD8E"]},"other_safety_information":["Warning: This product can expose you to coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause cancer. For more information fo to www.P65Warnings.ca.gov. 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 LEADER NDC 70000-0407-1 Antiseptic Skin Cleanser Chlorhexidine Gluconate 4% Solution Antiseptic / Antimicrobial Skin Cleanser For External Use Only COMPARE TO HIBICLENS ® active ingredient* 100% Money Back Guarantee 8 fl oz (237 mL) 4LEAD08BTLLBLE Leader 8oz 4% CHG single panel"],"purpose":["Purpose Antiseptic"],"questions":["Questions or comments? 1-800-587-3721"],"recent_major_changes":["Indications and Usage Dosage and Administration Directions (12/14) uses"],"set_id":"4a9eda34-d85c-4b66-e054-00144ff88e88","spl_product_data_elements":["ANTISEPTIC SKIN CLEANSER CHLORHEXIDINE GLUCONATE HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) ISOPROPYL ALCOHOL COCO DIETHANOLAMIDE WATER TRIDECYL ALCOHOL GLUCONOLACTONE PEG-75 LANOLIN CHLORHEXIDINE GLUCONATE CHLORHEXIDINE LAURAMINE OXIDE"],"storage_and_handling":["Other information store at 20-25ºC (68-77ºF) avoid excessive heat above 40ºC (104ºF)"],"version":"9","warnings":["Warnings For external use only Allergy alert: This product may cause a severe allergic reaction. Symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash If an allergic reaction occurs, stop use and seek medical help right away. Do not use if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product in contact with meninges in the genital area When using this product keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye 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 advised by a health care provider. 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 permitted to enter and remain in the eye 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 advised by a health care provider."]}