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

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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

Use

for the preparation of the patient’s skin prior to surgery. Helps to reduce

bacteria that potentially can cause skin infection.

Warnings

(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.

Other Information

• store between 15-30 oC (59-86 oF)

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

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

54365-400-34

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

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:54365-400-3425 in 1 CARTON05/24/2019
11 in 1 POUCH
110.5 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) , label(54365-400) , manufacture(54365-400) , pack(54365-400)

Revised: 6/2021
Document Id: c55fb03a-91d9-3cfe-e053-2a95a90a1ef2
Set id: 8541a1ed-2a92-1fab-e053-2a91aa0a29d1
Version: 3
Effective Time: 20210622
 
CareFusion 213, LLC