CHLORAPREP ONE-STEP- chlorhexidine gluconate and isopropyl alcohol solution 
CareFusion 213, LLC

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ChloraPrep Clear 26 mL Applicator

WARNING
FLAMMABLE

Keep away from fire or flame.

To reduce the risk of fire, PREP CAREFULLY:

smaller than 8.4 in. x 8.4 in. Use a smaller applicator instead.

dry. Wet hair is flammable.

is completely dry (minimum of 3 minutes on hairless skin; up to 1

hour in hair)

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:

Wet hair is flammable.

completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair)

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

13.2 in. x 13.2 in. (1126 cm2). Do not use 26-ml applicator for area smaller than

8.4 in. x 8.4 in. Use a smaller applicator instead. • do not use 26-ml applicator

for head and neck surgery • remove applicator from package; do not touch

sponge • hold the applicator with the sponge down. Pinch wing only once to

activate the ampules 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 • 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 oC (59-86 oF)

• avoid freezing and excessive heat above 40 oC (104 oF)

Inactive Ingredients

USP purified water

Questions?

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

Package Label

54365-400-37

Package Label-

BD ChloraPrep Clear

26 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

Clear

REF 930800

NDC 54365-400-37

External Use Only

Professional Use Only

STERILE EO

STERILE SOLUTION

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

CHLORAPREP ONE-STEP 
chlorhexidine gluconate and isopropyl alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54365-400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54365-400-371 in 1 POUCH05/24/2019
126 mL in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02083205/24/2019
Labeler - CareFusion 213, LLC (826496312)
Registrant - CareFusion 2200, Inc (832696038)
Establishment
NameAddressID/FEIBusiness Operations
CareFusion 213, LLC826496312analysis(54365-400) , manufacture(54365-400) , label(54365-400) , pack(54365-400)

Revised: 5/2019
Document Id: 85790749-5a96-7f18-e053-2a91aa0a1a02
Set id: 85790749-5a95-7f18-e053-2a91aa0a1a02
Version: 1
Effective Time: 20190524
 
CareFusion 213, LLC