CHLORAPREP ONE-STEP- chlorhexidine gluconate and isopropyl alcohol solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302), CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)

Available from:

CareFusion 213, LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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.

Authorization status:

New Drug Application

Summary of Product characteristics

CHLORAPREP ONE-STEP- CHLORHEXIDINE GLUCONATE AND ISOPROPYL
ALCOHOL SOLUTION
CAREFUSION 213, LLC
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CHLORAPREP 10.5 ML STERILE SOLUTION APPLICATORS; CLEAR, ORANGE, SCRUB
TEAL
WARNING. FLAMMABLE.
KEEP AWAY FROM FIRE OR FLAME.
_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;
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 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.
use in a well ventilated area
maximal t