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

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ChloraPrep® Clear 10.5 ml Applicator

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:

• 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

• before using this product see insert for important information
• to reduce the risk of fire the following strategies are recommended:
  • at the end of prep, discard any portion of the solution which is not required to cover the prep area. It is not necessary to use the entire amount available.
  • 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 materials from prep area
  • drape after solution is completely dry
• maximal treatment area for one applicator is approximately 8.4 in. x 8.4 in. (457 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 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

• 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

10.5 ml Carton 

 

NDC 054365-400-04

10.5ml APPLICATORS

Clear

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

0.36 fl. oz. (10.5 ml) each

ChloraPrep® One-Step

2% w/v chlorhexidine gluconate (CHG) and 70% 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

 

CHLORAPREP ONE-STEP  chlorhexidine gluconate and isopropyl alcohol   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 54365-400-04 25 POUCH In 1 CARTON contains a POUCH 1 1 APPLICATOR In 1 POUCH This package is contained within the CARTON (54365-400-04) and contains a APPLICATOR 1 10.5 mL In 1 APPLICATOR This package is contained within a POUCH and a CARTON (54365-400-04)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020832	07/14/2000

Labeler - CareFusion 213 LLC (830430810)

Registrant - CareFusion 213 LLC (831684456)

Establishment
Name	Address	ID/FEI	Operations
CareFusion 213 LLC		830430810	ANALYSIS, MANUFACTURE, LABEL, PACK

Revised: 11/2010CareFusion 213 LLC