A4148 NERVE BLOCK by Smiths Medical ASD, Inc. / CareFusion 213 LLC

A4148 NERVE BLOCK by

Drug Labeling and Warnings

A4148 NERVE BLOCK by is a Other medication manufactured, distributed, or labeled by Smiths Medical ASD, Inc., CareFusion 213 LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

A4148 NERVE BLOCK- anesthesia conduction kit   
Smiths Medical ASD, Inc.

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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

Chlorhexidine gluconate 2% w/v

Isopropyl alcohol 70% v/v

Antiseptic

for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.

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. Wethair 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 poolremove wet materials from prep area

Do not use

on patients with known allergies to chlorhexidine gluconate or isopropyl alcoholfor lumbar puncture or in contact with the meningeson 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.

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 cm 2)

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 of the sponge for approximately 30 seconds. Do not blot or wipe away.

moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes of the sponge for approximately 2 minutes. Allow solution to air dry for approximately 1 minute. Do not blot or wipe away.

If using an ignition source, 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.

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.

FD&C yellow #6 dye

USP purified water

www.chloraprep.comcall 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST)

Package Label Display Panel

Chloraprep Solution

Package Labe Display Panel

A4148

A4148 NERVE BLOCK 
anesthesia conduction kit kit
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:51688-6462
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:51688-6462-210 in 1 CASE; NCPDP billing unit = EA
1NHRIC:51688-6462-11 in 1 PACKAGE, COMBINATION; Type 1: Convenience Kit of Co-Package
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)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 54365-400-1125 in 1 CARTON
11 in 1 POUCH
13 mL in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02155508/18/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
premarket notificationK96501705/06/201401/15/2020
Labeler - Smiths Medical ASD, Inc. (137835299)
Establishment
NameAddressID/FEIBusiness Operations
Smiths Medical ASD, Inc.137835299manufacture
Establishment
NameAddressID/FEIBusiness Operations
CareFusion 213 LLC826496312manufacture

Revised: 1/2020
 
Smiths Medical ASD, Inc.