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.

To reduce the 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. 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

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 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

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 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 the 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 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 oC (59-86 oF)

avoid freezing and excessive heat above 40 oC (104 oF) 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

Package Label

BD ChloraPrep

Hi-Lite Orange

26 mL Applicator

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

REF 930815

NDC: 54365-400-38

Hi LIte Orange

External Use Only

Professional Use Only

STERILE EO

STERILE SOLUTION

CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co.

Made in the USA of US and imported parts www.bd.com

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: 54365-400-38	1 in 1 POUCH	05/24/2019
1		26 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	05/24/2019

Labeler - CareFusion 213, LLC (826496312)

Registrant - CareFusion 2200, Inc (832696038)

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