ACL11CH NERVE BLOCK  - regional anesthesia kit   
Smiths Medical ASD, Inc.

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CHLORAPREP ONE-STEP (chlorhexidine gluconate and isopropyl aclohol) solution
[CareFusion 213 LLC]

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 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 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

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.

Other information

store between 15-30 °C (59-86 °F)

avoid freezing and excessive heat above 40 °C (104 °F)

the tint will slowly fade from the skin. Soap and water, or alcohol may be used to remove the tint if desired.

Inactive ingredients

FD&C yellow #6 dye

USP purified water

Package Label Display Panel

Chloraprep Solution

Package Label Display Panel

ACL11CH

ACL11CH NERVE BLOCK  
regional anesthesia kit kit
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:55553-482
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:55553-482-0230 in 1 CASE
11 in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 APPLICATOR 3 mL
Part 1 of 1
CHLORAPREP ONE-STEP  
chlorhexidine gluconate and isopropyl alcohol solution
Product Information
Item Code (Source)NDC:54365-400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE20 mg  in 1 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.70 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54365-400-113 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02083208/18/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
premarket notificationK96501701/14/2014
Labeler - Smiths Medical ASD, Inc. (137835299)
Establishment
NameAddressID/FEIBusiness Operations
Smiths Medical ASD, Inc.137835299manufacture
Establishment
NameAddressID/FEIBusiness Operations
CareFusion 213 LLC830430778manufacture

Revised: 4/2014
Document Id: a2fbd285-a014-4415-9070-e7f022e7223d
Set id: 57a2935b-5741-43ce-9833-1de31eb02011
Version: 1
Effective Time: 20140414
 
Smiths Medical ASD, Inc.