Chloraprep One-Step

Generic Name: chlorhexidine gluconate and isopropyl alcohol
Dosage Form: solution

ChloraPrep® Frepp® Drug Facts

Active ingredient

Chlorhexidine gluconate 2% w/v

Isopropyl alcohol 70% v/v

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Purpose

Antiseptic

Uses

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 2.5 in. x 2.5 in. (42 cm2). Discard the applicator after a single use.
  • pinch the wings on the applicator to break the ampule and release the antiseptic. Do not touch 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 applicator 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 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?

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

Package/Label Principal Display Panel

Frepp Carton Primary Display Panel

NDC 054365-400-02

1.5ml FREPP APPLICATOR

Clear

Single Use

Latex Free

Applicator is STERILE if packaging is intact

20 applicators

0.05 fl. oz. (1.5ml) each

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)

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 (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  
Packaging
# Item Code Package Description
1 NDC:54365-400-02 20 POUCH (POUCH) in 1 CARTON
1 1 APPLICATOR (APPLICATOR) in 1 POUCH
1 1.5 mL in 1 APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020832 04/26/2002
Labeler - CareFusion 213 LLC (831684456)
Establishment
Name Address ID/FEI Operations
CareFusion 213 LLC 830430810 ANALYSIS, MANUFACTURE
Revised: 05/2010
 
CareFusion 213 LLC



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