CHLORAPREP ONE-STEP- chlorhexidine gluconate and isopropyl alcohol solution

ChloraPrep One-Step by

Drug Labeling and Warnings

ChloraPrep One-Step by is a Otc medication manufactured, distributed, or labeled by CareFusion 213 LLC, Becton, Dickinson and Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNING, FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME

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 4 in. x 5 in. (130 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 repeated back-and-forth strokes of the sponge for approximately 30 seconds. Allow solution to air dry for approximately 30 seconds. Do not blot or wipe away.
• moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes of the sponge for approximately 2 minutes. Allow solution to air dry for approximately 1 minute. Do not blot or wipe away.
• If using an ignition source, 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 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

PRINCIPAL DISPLAY PANEL-CARTON

3ml

APPLICATORS

Hi-Lite Orange®

Do Not Reuse

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

0.10 fl. oz. (3 ml) each

NDC: 054365-400-11

Cat. No. 260415

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

INGREDIENTS AND APPEARANCE

CHLORAPREP ONE-STEP 
chlorhexidine gluconate and isopropyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54365-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	20 mg  in 1 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54365-400-11	25 in 1 CARTON	08/18/2006
1		1 in 1 POUCH
1		3 mL in 1 APPLICATOR; Type 0: Not a Combination Product

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

Labeler - CareFusion 213 LLC (826496312)

Registrant - CareFusion 213 LLC (831684456)

Establishment
Name	Address	ID/FEI	Business Operations
CareFusion 213 LLC		826496312	analysis(54365-400) , manufacture(54365-400) , label(54365-400) , pack(54365-400)