Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L), ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)
CareFusion 213, LLC
TOPICAL
OTC DRUG
Antiseptic Antiseptic for the preparation of the patient’s skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection. • 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 irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
New Drug Application
CHLORAPREP ONE-STEP- CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL SOLUTION CAREFUSION 213, LLC ---------- CHLORAPREP SCRUB TEAL 26 ML APPLICATOR WARNING FLAMMABLE KEEP AWAY FROM FIRE OR FLAME. TO REDUCE THE RISK OF FIRE, PREP CAREFULLY: do not use 26-mL applicator for head and neck surgery or on an area smaller than 8.4 IN. X 8.4 IN. Use a smaller applicator instead. 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 _ACTIVE INGREDIENTS_ Chlorhexidine gluconate 2% w/v Isopropyl alcohol 70% v/v _PURPOSES_ Antiseptic Antiseptic USE for the preparation of the patient’s skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection. _WARNINGS_ FOR EXTERNAL USE ONLY. FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME. TO REDUCE RISK OF FIRE, PREP CAREFULLY: do not use 26-ml applicator for head and neck surgery do not use on an area smaller than 8.4 IN. X 8.4 IN. Use a smaller applicator instead. 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. 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 wo Perskaitykite visą dokumentą