CHLORAPREP ONE-STEP- chlorhexidine gluconate and isopropyl alcohol solution 
CareFusion 213 LLC
Reference Label Set Id: 8f37915a-292d-4f7b-881a-211d9d032c7e
Reference Label Set Id: 000506eb-0340-4d15-9dd1-71f10c83a3b9

----------

ChloraPrep® 26mL Non-Sterile Solution Applicators, Clear, Hi-Lite Orange, Scrub Teal

WARNING. FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME

Keep away from fire or flame.

To reduce risk of fire, PREP CAREFULLY:

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:

until solution is completely dry (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 meningea
  • 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

of age. These products may cause irritation or chemical burns.

13.2 in. x 13.2 in. (1126 cm 2). Do not use 26-ml applicator

for area smaller than 8.4 in. x 8.4 in. Use a smaller

applicator instead,

only once to activate the ampules and release the antiseptic.

against the treatment area until liquid is visible on the skin

repeated back-and-forth strokes for 30 seconds

repeated back-and-forth strokes for 2 minutes

solution, and then remove

minutes on hairless skin; up to 1 hour in hair). Do not

blot or wipe away.

portion of the solution not required to cover the prep area.

It is not necessary to use the entire amount available.

Other information

Inactive ingredient

USP purified water

Questions?

Package Label: 26mL Applicators Non-Sterile Solution: Clear, Hi-Lite Orange, Scrub Teal

ChloraPrep 26 ml Clear

54365-400-13

54365-400-05

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:54365-400-141 in 1 POUCH07/14/2000
126 mL in 1 APPLICATOR; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
2NDC:54365-400-131 in 1 POUCH08/18/2006
226 mL in 1 APPLICATOR; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
3NDC:54365-400-051 in 1 POUCH04/26/2002
326 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: 0a1f7394-bd4f-b627-e063-6394a90a0a90
Set id: adf7e698-bfbb-49b8-961e-dde1b2d34fb6
Version: 19
Effective Time: 20231114
 
CareFusion 213 LLC