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ChloraPrep One-Step by CareFusion 213 LLC

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

ChloraPrep® Clear 26ml Applicator

WARNING. FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME

Keep away from fire or flame.

To reduce risk of fire, PREP CAREFULLY:

  • do not use 26-ml applicator for head and neck surgery or on an area smaller than 8.4 in. × 8.4 in. Use a smaller applicator instead.
  • 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

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:

  • do not use 26-mL applicator for head and neck surgery
  • do not use on an area smaller than 8.4 in. x 8.4 in. Use a smaller applicator instead.
  • 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 allergic to chlorhexidine gluconate or any other ingredient in this product
  • for lumbar puncture or in contact with the meningea
  • 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

13.2 in. x 13.2 in. (1126 cm 2). Do not use 26-ml applicator

for area smaller than 8.4 in. x 8.4 in. Use a smaller

applicator instead,

  • do not use 26-ml applicator for head and neck surgery
  • remove applicator from package; do not touch sponge
  • hold applicator with the sponge down. Pinch wing

only once to activate the ampules 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

repeated back-and-forth strokes for 30 seconds

  • moist surgical sites (e.g., inguinal fold): use gentle

repeated back-and-forth strokes for 2 minutes

  • do not allow solution to pool; tuck prep towels to absorb

solution, and then remove

  • allow 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 ingredient

USP purified water

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

Package Label

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
WATER 
Packaging
#Item CodePackage Description
1NDC:54365-400-141 APPLICATOR in 1 POUCH
126 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02083207/14/2000
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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Medically reviewed on Sep 27, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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