CHLORAPREP SWABSTICK- chlorhexidine gluconate and isopropyl alcohol solution 
CareFusion 213 LLC

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ChloraPrep™ Swabsticks

Active ingredients

Chlorhexidine gluconate (CHG), 2% w/v

and Isopropyl alcohol (IPA), 70% v/v

Purpose

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 ingredient

Questions?

Package/Label Principal Display Panel

54365-401-28

PRINCIPAL DISPLAY PANEL-CARTON

BD ChloraPrep™ Single Swabstick

Chlorhexidine gluconate (CHG), 2% w/v

and Isopropyl alcohol (IPA), 70% v/v Swab

Patient Preoperative Skin Preparation

Sterile Solution

Applicator is sterile if package is intact

1.75 mL Applicators

NDC 054365-401-28

Ref 930100

54365-401-29

PRINCIPAL DISPLAY PANEL-CARTON

BD ChloraPrep™ Triple Swabstick

Chlorhexidine gluconate (CHG), 2% w/v

and Isopropyl alcohol (IPA), 70% v/v Swab

Patient Preoperative Skin Preparation

Sterile Solution

Applicator is sterile if package is intact

5.25 mL Applicators

NDC 054365-401-29

Ref 930103

CHLORAPREP SWABSTICK 
chlorhexidine gluconate and isopropyl alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54365-401
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:54365-401-2848 in 1 CARTON05/13/2024
11 in 1 POUCH
11.75 mL in 1 APPLICATOR; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
2NDC:54365-401-2940 in 1 CARTON05/13/2024
23 in 1 POUCH
25.25 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
NDANDA02155505/13/2024
Labeler - CareFusion 213 LLC (826496312)
Registrant - Becton, Dickinson and Company (832696038)
Establishment
NameAddressID/FEIBusiness Operations
CareFusion 213 LLC826496312manufacture(54365-401) , analysis(54365-401) , label(54365-401) , pack(54365-401) , sterilize(54365-401)

Revised: 4/2024
Document Id: 1665eb0f-2c42-6c6b-e063-6294a90a8c0f
Set id: 1666069b-38f6-bfde-e063-6394a90ad1b8
Version: 1
Effective Time: 20240423
 
CareFusion 213 LLC