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FDA > Chloraprep One-Step

Chloraprep One-Step

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Generic Name: chlorhexidine gluconate and 70% v/v isopropyl alcohol
Dosage Form: solution, preoperative skin preparation
ChloraPrep® With Tint
2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)
Patient Preoperative Skin Preparation
3ml
APPLICATOR
Hi-Lite Orange®
WARNING. FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.
Cat. No. 260415
NDC 054365-400-11
Single Use
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

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 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

  • 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 4 in. x 5 in (130cm2). Discard the applicator after a single use.
  • pinch the wings on the applicator to break the ampule and release the antiseptic. Do not touch the sponge. Wet the sponge by repeatedly pressing and releasing the sponge 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 sponge for approximately 30 seconds. Completely wet the treatment area with antiseptic. Allow the 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 sponge 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

  • FD&C yellow #6 dye
  • USP purified water

QUESTIONS?

Call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST)

  • www.chloraprep.com

PRINCIPAL DISPLAY PANEL - CARTON (FRONT AND SIDE)

NDC 054365-400-11

3 ml
APPLICATORS

Hi-Lite Orange®

Single Use

Latex Free

Applicator is STERILE if package is intact

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

25 applicators

ChloraPrep®
With Tint
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

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

WARNING. FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.

3 ml
APPLICATORS

Hi-Lite Orange®

25 applicators

ChloraPrep®
With Tint
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 orange (FD&C Yellow #6) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 54365-400-11 25 POUCH In 1 CARTON contains a POUCH
1 1 APPLICATOR In 1 POUCH This package is contained within the CARTON (54365-400-11) and contains a APPLICATOR
1 3 mL In 1 APPLICATOR This package is contained within a POUCH and a CARTON (54365-400-11)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020832 08/18/2006

Labeler - CareFusion 213 LLC (831684456)
Establishment
Name Address ID/FEI Operations
CareFusion 213 LLC 830430810 manufacture
Revised: 10/2009CareFusion 213 LLC



 


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