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ChloraPrep One-Step by CareFusion 213 LLC

Medically reviewed on September 27, 2017

Dosage form: solution
Ingredients: CHLORHEXIDINE GLUCONATE 20mg in 1mL, ISOPROPYL ALCOHOL 0.7mL in 1mL
Labeler: CareFusion 213 LLC
NDC Code: 54365-400

ChloraPrep® Scrub Teal® 10.5ml Applicator

WARNING. FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.

Keep away from fire or flame.

To reduce risk of fire, PREP CAREFULLY:

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

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
  • avoid getting solution into hairy areas. 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)
  • do not allow solution to pool
  • remove wet materials from prep area

Allergy alert:

This product may cause a severe allergic reaction. Symptoms may include:

  • wheezing/difficulty breathing
  • shock
  • facial swelling
  • hives
  • rash

If an allergic reaction occurs, stop use and seek medical help right away.

Do not use
  • on patients with known allergies to chlorhexidine gluconate or any other ingredient in this product.
  • 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
  • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
  • use in a well ventilated area
  • maximal treatment area for one applicator is approximately 8.4 in. x 8.4 in. (457 cm 2)
  • remove applicator from package; do not touch sponge
  • hold the applicator with the sponge down. Pinch wings only once to activate the ampule and release the antiseptic.
  • wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skin
  • completely wet the treatment area with antiseptic
  • dry surgical sites (e.g., abdomen or arm): use gentle back-and-forth strokes for 30 seconds
  • moist surgical sites (e.g., inguinal fold): use gentle back-and-forth strokes for 2 minutes
  • do not allow the solution to pool; tuck prep towels to absorb solution, and then remove
  • allow the solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). Do not blot or wipe away.
  • discard the applicator after a single use along with any portion of the solution not required to cover the prep area. It is not necessary to use the entire amount available.

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

Inactive ingredients

FD&C green #3 dye, 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

PRINCIPAL DISPLAY PANEL-CARTON

10.5 ml

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

NDC 054365-400-09

Cat. No. 260725

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:

  • solution contains alcohol and gives off flammable vapors
  • avoid getting solution iinto hairy areas

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)

  • do not alllow solution to pool
  • remove wet materials from prep area
CHLORAPREP ONE-STEP 
chlorhexidine gluconate and isopropyl alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54365-400
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE20 mg  in 1 mL
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
FD&C GREEN NO. 3 
WATER 
Packaging
#Item CodePackage Description
1NDC:54365-400-0925 POUCH in 1 CARTON
11 APPLICATOR in 1 POUCH
110.5 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02083204/26/2002
Labeler - CareFusion 213 LLC (826496312)
Registrant - CareFusion 2200, Inc (832696038)
Establishment
NameAddressID/FEIOperations
CareFusion 213 LLC826496312analysis(54365-400), manufacture(54365-400), label(54365-400), pack(54365-400)

 
CareFusion 213 LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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