CHLORAPREP ONE-STEP- chlorhexidine gluconate and isopropyl alcohol solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Chlorhexidine gluconate 2% w/v, Isopropyl alcohol 70% v/v
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
Authorization number:
54365-400-34

CHLORAPREP ONE-STEP- chlorhexidine gluconate and isopropyl alcohol solution

CareFusion 213, LLC

----------

ChloraPrep Clear 10.5 mL Applicator

WARNING. FLAMMABLE.

KEEP AWAY FROM FIRE OR FLAME.

Active ingredients

Chlorhexidine gluconate 2% w/v

Isopropyl alcohol 70% v/v

Purposes

Antiseptic

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 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 treatment area for one applicator is approximately 8.4 in. x 8.4 in. (457 cm2)

remove applicator from package; do not touchsponge

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 surgicalsites (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

do not allow solution to pool; tuck prep towels to absorb solution, and then remove

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

avoid freezing and excessive heat above 40

C (104

Inactive Ingredient

USP purified water

Questions?

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

Principal Display Panel-Carton

Principal Display Panel-Carton

BD ChloraPrep Clear

10.5 mL Applicator

2% w/v chlorhexidine gluconate (CHG)

and 70% v/v Isopropyl alcohol (IPA)

Patient Preoperative Skin Preparation

Sterile Solution

Applicator is sterile if package is intact

Store between 15-30 oC (59-86 oF)

Avoid freezing and excessive heat above 40 oC (104 oF)

0.36 fl. oz. (10.5 mL) each

25 Applicators

NDC 54365-400-34

REF 930700

WARNING

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

Not made with natural rubber latex

Do not reuse

STERILE EO

STERILE SOLUTION

External Use Only

Professional Use Only

CareFusion 213, LLC, El Paso, TX 79912. subsidiary of Becton, Dickinson and Co. Made in the USA

of US and imported parts www.bd.com

CareFusion 213, LLC

CHLORAPREP ONE-STEP

chlorhexidine gluconate and isopropyl alcohol solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:5436 5-40 0

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2) (ISOPROPYL ALCOHOL -

UNII:ND2M416 30 2)

ISOPROPYL ALCOHOL

0 .7 mL

in 1 mL

CHLO RHEXIDINE GLUCO NATE (UNII: MOR8 4MUD8 E) (CHLORHEXIDINE -

UNII:R4KO0 DY52L)

CHLORHEXIDINE

GLUCONATE

20 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:5436 5-40 0 -

25 in 1 CARTON

0 5/24/20 19

1

1 in 1 POUCH

1

10 .5 mL in 1 APPLICATOR; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 20 8 32

0 5/24/20 19

Labeler -

CareFusion 213, LLC (826496312)

Registrant -

CareFusion 2200, Inc. (832696038)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

CareFusio n 213, LLC

8 26 49 6 312

analysis(5436 5-40 0 ) , label(5436 5-40 0 ) , manufacture(5436 5-40 0 ) , pack(5436 5-40 0 )

Revised: 5/2019

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