{"active_ingredient":["Active ingredients Chlorhexidine gluconate 2% w/v Isopropyl alcohol 70% v/v"],"do_not_use":["Do not use • on patients allergic to chlorhexidine gluconate or any other ingredient in this product • for lumbar puncture or in contact with the meninges • on open skin wounds or as a general skin cleanser"],"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. use in a well ventilated area maximal treatment area for one applicator is approximately 8.4 in. x 8.4 in. (457 cm 2 ) remove applicator from package; do not touch sponge hold the applicator with the sponge down. Pinch wings only once to activate the ampule and release the antiseptic. wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skin completely wet the treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use gentle repeated back-and-forth strokes for 30 seconds moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes for 2 minutes do not allow solution to pool; tuck prep towels to absorb solution, and then remove allow the solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). Do not blot or wipe away. discard the applicator after a single use along with any portion of the solution not required to cover the prep area. It is not necessary to use the entire amount available."],"effective_time":"20251023","id":"41db8350-addc-ea0a-e063-6294a90a4a93","inactive_ingredient":["Inactive ingredients USP purified water"],"indications_and_usage":["Use for the preparation of the patient’s skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection."],"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":["NDA020832"],"brand_name":["ChloraPrep One-Step"],"generic_name":["CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL"],"is_original_packager":[true],"manufacturer_name":["CareFusion 213, LLC"],"package_ndc":["54365-400-34"],"product_ndc":["54365-400"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["858726","998282"],"spl_id":["41db8350-addc-ea0a-e063-6294a90a4a93"],"spl_set_id":["8541a1ed-2a92-1fab-e053-2a91aa0a29d1"],"substance_name":["ISOPROPYL ALCOHOL","CHLORHEXIDINE GLUCONATE"],"unii":["ND2M416302","MOR84MUD8E"]},"other_safety_information":["Other Information • store between 15-30 °C (59-86 ° F) • avoid freezing and excessive heat above 40 ° C (104 °F)"],"package_label_principal_display_panel":["BD ChloraPrep™ Clear 10.5 mL Applicator with Sterile Solution Principal Display Panel-Package and Carton Label BD ChloraPrep™ Clear 10.5 mL Applicators 2% w/v chlorhexidine gluconate (CHG) and 70% v/v Isopropyl alcohol (IPA) Patient Preoperative Skin Preparation Sterile Solution Applicator is sterile if package is intact Store between 15-30 °C (59-86 °F) Avoid freezing and excessive heat above 40 °C (104 °F) 0.36 fl. oz. (10.5 mL) each 25 Applicators Clear NDC 54365-400-34 REF 930700 10.5 Clear Pouch 10.5 Clear Carton"],"purpose":["Purposes Antiseptic Antiseptic"],"questions":["Questions? www.chloraprep.com • call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST)"],"set_id":"8541a1ed-2a92-1fab-e053-2a91aa0a29d1","spl_product_data_elements":["ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL WATER CHLORHEXIDINE GLUCONATE CHLORHEXIDINE"],"stop_use":["Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition."],"version":"11","warnings":["WARNING FLAMMABLE Keep away from fire or flame. To reduce risk of fire, PREP CAREFULLY: solution contains alcohol and gives off flammable vapors avoid getting solution into hairy areas. Hair may take up to 1 hour to dry. Wet hair is flammable. do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair) do not allow solution to pool remove wet materials from prep area","Warnings For external use only. Flammable, keep away from fire or flame. To reduce risk of fire, PREP CAREFULLY: solution contains alcohol and gives off flammable vapors avoid getting solution into hairy areas. Hair may take up to 1 hour to dry. Wet hair is flammable. do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair) do not allow solution to pool remove wet materials from prep area","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."],"when_using":["When using this product keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor."]}