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

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ChloraPrep® Hi-Lite Orange® 3ml

WARNING, FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME

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

FD&C yellow #6 dye

USP purified water

Questions?

Package/Label Principal Display Panel

ChloraPrep 3 mL Hi-Lite Orange

PRINCIPAL DISPLAY PANEL-CARTON

3ml

APPLICATORS

Hi-Lite Orange®

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)

25 applicators

0.10 fl. oz. (3 ml) each

NDC 054365-400-11

Cat. No. 260415

ChloraPrep® With Tint

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 Type HUMAN OTC DRUG Item Code (Source) NDC:54365-400
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 20 mg  in 1 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 0.7 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54365-400-11 25 in 1 CARTON 08/18/2006
1 1 in 1 POUCH
1 3 mL in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020832 08/18/2006
Labeler - CareFusion 213 LLC (826496312)
Registrant - CareFusion 213 LLC (831684456)
Establishment
Name Address ID/FEI Business Operations
CareFusion 213 LLC 826496312 analysis(54365-400) , manufacture(54365-400) , label(54365-400) , pack(54365-400)

Revised: 9/2017
Document Id: 5a2e9a41-0a97-3baf-e053-2a91aa0a082e
Set id: cf938014-57fc-4ff2-92a0-6dee1e69c4d8
Version: 8
Effective Time: 20170928
 
CareFusion 213 LLC