A4077 NERVE BLOCK - regional anesthesia kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Smiths Medical ASD, Inc.

INN (International Name):

CHLORHEXIDINE GLUCONATE

Composition:

CHLORHEXIDINE GLUCONATE 20 mg in 1 mL

Therapeutic indications:

Purposes Antiseptic Use for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.             Do not use - on patients with known allergies to chlorhexidine gluconate or isopropyl alcohol - for lumbar puncture or in contact with the meninges - on open skin wounds or as a general skin cleanser            Stop use and ask a doctor if - irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.            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 4 in. x 5 in. (130 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 unt

Authorization status:

Premarket Notification

Summary of Product characteristics

A4077 NERVE BLOCK - REGIONAL ANESTHESIA KIT
SMITHS MEDICAL ASD, INC.
----------
CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ACLOHOL)
SOLUTION
[CAREFUSION 213 LLC]
ACTIVE INGREDIENTS
Chlorhexidine guluconate 2% w/v
Isopropyl alchohol 70% v/v
PURPOS ES
Antiseptic
US E
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 the 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 DO NOT USE
on patients with known allergies to chlorhexidine gluconate or
isopropyl alcohol
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 treatment area for one applicator is approximately 4 in. x 5
in. (130 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