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

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ChloraPrep One-Step 1 mL applicator

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.

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

Other information

Inactive ingredients

USP purified water

Questions?

Package/Label Principle Display Panel

ChloraPrep 1 mL

PRINCIPAL DISPLAY PANEL-CARTON

1 mL

APPLICATORS

Clear

Do Not Reuse

Not made with natural rubber latex

STERILE EO

Professional Use Only

Store between 15 - 30°C (59 - 86°F)

Avoid freezing and excessive heat

above 40°C (104°F)

60 applicators

0.03 fl. oz. (1 mL) each

NDC 054365-400-06

Cat. No. 260480

ChloraPrep ® One-Step

2% w/v chlorhexidine gluconate (CHG)

and 70% v/v isopropyl alcohol (IPA)

Patient Preoperative Skin Preparation

Non-sterile Solution

Applicator is sterile if package is intact

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
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE20 mg  in 1 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54365-400-0660 in 1 CARTON07/23/2014
11 in 1 POUCH
11 mL in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02083207/23/2014
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: 6/2019
Document Id: 8b23770c-5200-b7ef-e053-2995a90a74de
Set id: 044e24de-c76b-0161-e054-00144ff8d46c
Version: 5
Effective Time: 20190612
 
CareFusion 213 LLC