CHLORAPREP ONE-STEP- chlorhexidine gluconate and isopropyl alcohol solution 
CareFusion 213 LLC
Reference Label Set Id: c15766f7-e6ab-4d9e-bf90-deabab2c7b20
Reference Label Set Id: 77a8858e-2b3e-4b13-83ed-c989b7cc554c

----------

ChloraPrep® 10.5mL Non-Sterile Solution Applicator: Clear, Hi-Lite Orange, Scrub Teal

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 the risk of fire, PREP CAREFULLY:

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 with known allergies 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 10.5mL Applicators Non-Sterile Solution: Clear, Hi-Lite Orange, Scrub Teal

ChloraPrep 10.5mL Hi-Lite OrangeChloraPrep 10.5 mL Clear

PRINCIPAL DISPLAY PANEL-CARTON

10.5 ml

APPLICATORS

Clear

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)

25 applicators

0.36 fl. oz. (10.5 ml) each

NDC 054365-400-04

Cat. No. 260700

ChloraPrep® One-Step

2% w/v chlorhexidine gluconate (CHG)

and 70% isopropyl alcohol (IPA)

Patient Preoperative Skin Preparation

Non-sterile Solution

Applicator is sterile if package is intact

WARNING FLAMMABLE

Keep away from fire or flame.

To reduce risk of fire, PREP CAREFULLY:

Hair may take up to 1 hour to dry. Wet hair is flammable.

laser) until solution is completely dry (minimum of

3 minutes on hairless skin; up to 1 hour in hair)

PRINCIPAL DISPLAY PANEL-CARTON

10.5 ml

APPLICATORS

Hi-Lite Orange

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)

25 applicators

0.36 fl. oz. (10.5 ml) each

NDC 054365-400-12

Cat. No. 260715

ChloraPrep ® With Tint

2% w/v chlorhexidine gluconate (CHG)

and 70% isopropyl alcohol (IPA)

Patient Preoperative Skin Preparation

Non-sterile Solution

Applicator is sterile if package is intact

WARNING FLAMMABLE

Keep away from fire or flame.

To reduce risk of fire, PREP CAREFULLY:

Hair may take up to 1 hour to dry. Wet hair is flammable.

laser) until solution is completely dry (minimum of

3 minutes on hairless skin; up to 1 hour in hair)

54365-400-09

PRINCIPAL DISPLAY PANEL-CARTON

10.5 ml

APPLICATORS

Scrub Teal

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)

25 applicators

0.36 fl. oz. (10.5 ml) each

NDC 054365-400-09

Cat. No. 260725

ChloraPrep® With Tint

2% w/v chlorhexidine gluconate (CHG)

and 70% isopropyl alcohol (IPA)

Patient Preoperative Skin Preparation

Non-sterile Solution

Applicator is sterile if package is intact

WARNING FLAMMABLE

Keep away from fire or flame.

To reduce risk of fire, PREP CAREFULLY:

Hair may take up to 1 hour to dry. Wet hair is flammable.

laser) until solution is completely dry (minimum of

3 minutes on hairless skin; up to 1 hour in hair)

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:54365-400-0425 in 1 CARTON07/14/2000
11 in 1 POUCH
110.5 mL in 1 APPLICATOR; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
2NDC:54365-400-1225 in 1 CARTON08/18/2006
21 in 1 POUCH
210.5 mL in 1 APPLICATOR; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
3NDC:54365-400-0925 in 1 CARTON04/26/2002
31 in 1 POUCH
310.5 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
NDANDA02083207/14/2000
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: 0a207445-d6c7-1add-e063-6394a90ae9ba
Set id: 3f94d971-0d96-47a2-9117-540dfd1278a6
Version: 17
Effective Time: 20231114
 
CareFusion 213 LLC