ChloraPrep One-Step description, usages, side effects, indications, overdosage, supplying and lots more!

ChloraPrep One-Step

CareFusion 213 LLC
CareFusion 2200, Inc

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
ChloraPrep® Hi-Lite Orange® 26ml Applicator

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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 small 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

Do not use

  • •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

  • •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 cm2). 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)
  • •the tint will slowly fade from the skin. Soap and water, or alcohol may be used to remove the tint if desired.

Inactive ingredients

  • •FD&C yellow #6 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

26ml Hi-Lite Orange Primary Display

26ml Hi-Lite Orange Primary Display

Cat. No. 260815

NDC 054365-400-13

Single Use

Applicator is sterile if package is intact

ChloraPrep® With Tint

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

Patient Preoperative Skin Preparation

26ml APPLICATOR

Hi-Lite Orange®

WARNING. FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.

CareFusion, El Paso, TX 79912

Made in USA of US and imported parts

ChloraPrep One-Step

chlorhexidine gluconate and isopropyl alcohol SOLUTION

Product Information

Product Type Human otc drug label 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 20 mg
ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL 0.7 mL

Inactive Ingredients

Ingredient Name Strength
water
FD&C YELLOW NO. 6

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 26 in 1 APPLICATOR
2 NDC:54365-400-13 1 in 1 POUCH

Marketing Information

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


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Be sure to consult your doctor before taking any medication!
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