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

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ChloraPrep® Frepp® Non-Sterile Solution

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 occurrs, 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 Principal Display Panel

ChloraPrep FREPP

PRINCIPAL DISPLAY PANEL-CARTON

1.5ml

FREPP ®

APPLICATORS

Clear

Do Not Reuse

Not made with natural rubber latex

STERILE EO

20 applicators

0.05 fl. oz. (1.5ml) each

NDC 054365-400-02

Cat. No.260299

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

Professional Use Only

Store between 15-30 °C (59-86 °F)

Avoid freezing and excessive heat above 40 °C (104 °F)

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:54365-400-0220 in 1 CARTON04/26/2002
11 in 1 POUCH
11.5 mL in 1 APPLICATOR; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02083204/26/2002
Labeler - CareFusion 213 LLC (826496312)
Registrant - Becton, Dickinson and Company (832696038)
Establishment
NameAddressID/FEIBusiness Operations
CareFusion 213 LLC826496312analysis(54365-400) , manufacture(54365-400) , label(54365-400) , pack(54365-400) , sterilize(54365-400)

Revised: 11/2023
Document Id: 0a218eb6-b1fc-fa33-e063-6294a90a57d4
Set id: 5b390556-5379-4367-9b1f-5670354fff7f
Version: 15
Effective Time: 20231114
 
CareFusion 213 LLC