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

----------

ChloraPrep® Scrub Teal® 10.5ml Applicator

WARNING FLAMMABLE

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

Do not use

  • on patients with known allergies to chlorhexidine gluconate or isopropyl alcohol
  • 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

Questions?

WARNING FLAMMABLE

Package/Label Principal Display Panel

10.5ml Teal Carton Primary Display Panel

Carton Front Panel

NDC 054365-400-09

10.5ml 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

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

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.

do not drape or use ignition source (e.g., cautery, 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 Type HUMAN OTC DRUG Item Code (Source) NDC:54365-400
Route of Administration TOPICAL DEA Schedule     
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 .7 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54365-400-09 25 in 1 CARTON
1 1 in 1 POUCH
1 10.5 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 04/26/2002
Labeler - CareFusion 213 LLC (826496312)
Registrant - CareFusion 2200, Inc (832696038)
Establishment
Name Address ID/FEI Business Operations
CareFusion 213 LLC 826496312 analysis(54365-400) , manufacture(54365-400) , label(54365-400) , pack(54365-400)

Revised: 4/2015
Document Id: 12d8d41a-09d7-4032-e054-00144ff8d46c
Set id: c15766f7-e6ab-4d9e-bf90-deabab2c7b20
Version: 9
Effective Time: 20150403
 
CareFusion 213 LLC