Chloraprep One-Step Prescribing Information

Warnings

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. 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

Indications and Usage for Chloraprep One-Step

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 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

Warnings

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 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.

Chloraprep One-Step Dosage and Administration

• 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 surgicalsites (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 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)

Questions?

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

Principal Display Panel-Carton 10.5 mL Sterile Applicators: Clear, Hi-Lite Orange, or Scrub Teal

Principal Display Panel-Carton

BD ChloraPrep™ Clear

10.5 mL Applicators

2% w/v chlorhexidine gluconate (CHG)

and 70% v/v Isopropyl alcohol (IPA)

Patient Preoperative Skin Preparation

Sterile Solution

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)

0.36 fl. oz. (10.5 mL) each

25 Applicators

Clear

NDC 54365-400-34

REF 930700

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 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

Principal Display Panel-Carton

BD ChloraPrep™ Hi-Lite Orange™

10.5 mL Applicators

2% w/v chlorhexidine gluconate (CHG)

and 70% v/v Isopropyl alcohol (IPA)

Patient Preoperative Skin Preparation

Sterile Solution

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)

0.36 fl. oz. (10.5 mL) each

25 Applicators

Hi-Lite Orange™

NDC 54365-400-35

REF 930715

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 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

Principal Display Panel-Carton

BD ChloraPrep™ Scrub Teal™

10.5 mL Applicators

2% w/v chlorhexidine gluconate (CHG)

and 70% v/v Isopropyl alcohol (IPA)

Patient Preoperative Skin Preparation

Sterile Solution

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)

0.36 fl. oz. (10.5 mL) each

25 Applicators

Scrub Teal™

NDC 54365-400-36

REF 930725

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 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