البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: 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 STERILE SOLUTION FREPP CLEAR 1.5 ML APPLICATORS _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. • do not use with electrocautery procedures 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 wounds or as a general skin cleanser 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. 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. _DIRECTIONS_ • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. • maximal treatment area for one applicator is approximately 2.5 IN. X 2.5 IN. (42 CM2) • 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., abdo اقرأ الوثيقة كاملة