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

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ChloraPrep® One-Step
2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)
Patient Preoperative Skin Preparation
0.67ml
SEPP®
APPLICATORS
Clear
WARNING. FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.
Cat. No. 260449
NDC 054365-400-03
Single Use
Latex Free
Applicator is STERILE if package is intact

ACTIVE INGREDIENTS

Chlorhexidine gluconate 2% w/v

Isopropyl alcohol 70% v/v

PURPOSE

Antiseptic

USE

Use for the preparation of the patient’s skin prior to surgery or injection.

WARNINGS

For external use only. Flammable, keep away from fire or flame. To reduce risk of fire, PREP CAREFULLY:

• solution contains alcohol and gives off flammable vapors
• 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).
• avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry.
• do not allow solution to pool
• remove wet materials from prep area

Do not use

• in children less than 2 months of age because of the potential for excessive skin irritation and increased drug absorption
• on patients with known allergies to chlorhexidine gluconate or isopropyl alcohol
• for lumbar puncture or in contact with the meninges
• on open skin 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

• to reduce the risk of fire the following strategies are recommended:
  • use in a well ventilated area
  • avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry.
  • do not allow solution to pool
  • tuck prep towels to absorb solution, and then remove
  • remove wet material from prep area

• maximal treatment area for one applicator is approximately 2.5 in. x 2.5 in. (42 cm2). Discard the applicator after a single use.
• pinch the barrel on the applicator to break the ampule and release the antiseptic. Do not touch applicator tip. Press the applicator tip against the treatment area until liquid is visible on the skin.
• dry surgical sites (such as abdomen or arm): Use repeated back-and-forth strokes of the applicator for approximately 30 seconds. Completely wet the treatment area with antiseptic. Allow area to air dry for approximately 30 seconds. Do not blot or wipe away.
• moist surgical sites (such as the inguinal fold): Use repeated back-and-forth strokes of the applicator for approximately 2 minutes. Completely wet the treatment area with antiseptic. Allow the area to air dry for approximately one (1) minute. Do not blot or wipe away.

OTHER INFORMATION

• store between 15-30 °C (59-86 °F)
• avoid freezing and excessive heat above 40 °C (104 °F)

INACTIVE INGREDIENTS

• USP purified water

QUESTIONS

• call 1-800-523-0502 (M-F 8a.m.-5 p.m. CST)
• www.chloraprep.com

PRINCIPAL DISPLAY PANEL - CARTON (FRONT AND SIDE)

NDC 054365-400-03

0.67ml
SEPP®
APPLICATORS

Clear

Single Use

Latex Free

Applicator is STERILE if package is intact

200 applicators

ChloraPrep®
One-Step
2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)
Patient Preoperative Skin Preparation

WARNING
FLAMMABLE

Keep away from fire or flame.

To reduce risk of fire, PREP CAREFULLY:

• solution contains alcohol and gives off flammable vapors
• 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).
• avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry.
• do not allow solution to pool
• remove wet material from prep area

Store between 15-30 °C (59-86 °F)
Avoid freezing and excessive heat above 40 °C (104 °F)

PRINCIPAL DISPLAY PANEL - CARTON (BACK, TOP, AND SIDE)

WARNING. FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.

0.67ml
SEPP®
APPLICATORS

Clear

200 applicators

ChloraPrep®
One-Step
2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)
Patient Preoperative Skin Preparation

CareFusion

Leawood, KS 66211

1.800.523.0502

www.chloraprep.com

Made in USA

CHLORAPREP ONE-STEP  chloraprep one-step   solution

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 54365-400 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE 20 mg  in 1 mL ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 0.70 mL  in 1 mL

Inactive Ingredients Ingredient Name Strength WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 54365-400-03 200 POUCH In 1 CARTON contains a POUCH 1 1 APPLICATOR In 1 POUCH This package is contained within the CARTON (54365-400-03) and contains a APPLICATOR 1 0.67 mL In 1 APPLICATOR This package is contained within a POUCH and a CARTON (54365-400-03)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021555	10/07/2002

Labeler - CareFusion 213 LLC (831684456)

Establishment
Name	Address	ID/FEI	Operations
CareFusion 213 LLC		830430810	MANUFACTURE

Revised: 12/2009CareFusion 213 LLC