ChloraPrep One-Step

Manufacturer: CareFusion 213 LLC | Becton, Dickinson and Company
Effective date: 2024-12-13
Label type: HUMAN OTC DRUG LABEL
Version: 11
Source: legacy-cache
Hydrated at: 2026-08-01 20:45:50

Label at a glance#

ProductChloraPrep One-Step

Active ingredientCHLORHEXIDINE GLUCONATE, ISOPROPYL ALCOHOL

Label structure9 sections

Dosage and administration

use with care in premature infants or in infants under 2 months of age. These products may cause irritation or chemical burns. maximal treatment area for one applicator is approximately 2.5 in. × 2.5 in. (42 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 rele...

Storage and handling

store between 15 - 30°C (59 - 86°F). avoid freezing and excessive heat above 40°C (104°F).

Contacts and useful links#

PhoneLabel contact1-800-523-0502

Websitewww.chloraprep.com

www.chloraprep.com

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Chlorhexidine gluconate 2% w/v

Isopropyl alcohol 70% v/v

Purposes

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.

Warnings

WARNINGS SECTION

For external use only. Flammable, keep away from fire or flame.

do not use with electrocautery procedures

Allergy alert:

WARNINGS SECTION

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

WARNINGS SECTION

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

WARNINGS SECTION

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

WARNINGS SECTION

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

use with care in premature infants or in infants under 2 months of age. These products may cause irritation or chemical burns.
maximal treatment area for one applicator is approximately 2.5 in. × 2.5 in. (42 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 for approximately 30 seconds. Allow the area to air dry for approximately 30 seconds.
moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes for approximately 2 minutes. Allow the area to air dry for approximately 1 minute.
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

STORAGE AND HANDLING SECTION

store between 15 - 30°C (59 - 86°F).
avoid freezing and excessive heat above 40°C (104°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

USP purified water

Questions?

OTHER SAFETY INFORMATION

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

Package/Label Principle Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ChloraPrep 1 mL

PRINCIPAL DISPLAY PANEL-CARTON

1 mL

APPLICATORS

Clear

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)

60 applicators

0.03 fl. oz. (1 mL) each

NDC 054365-400-06

Cat. No. 260480

ChloraPrep ^® One-Step

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54365-400-06	2025-07-29	C162847	48780-1	3b156c62-288b-fb37-e063-e6dba90a4e07	ChloraPrep One-Step 1mL Non-sterile applicator

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	2
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	2
CHLORHEXIDINE	ACTIVE MOIETY	R4KO0DY52L	2
ISOPROPYL ALCOHOL	ACTIVE MOIETY	ND2M416302	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

ChloraPrep One-Step
chlorhexidine gluconate and isopropyl alcohol
WATER
CHLORHEXIDINE GLUCONATE
CHLORHEXIDINE
ISOPROPYL ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54365-400	54365-400-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
CHLORHEXIDINE GLUCONATE	MOR84MUD8E	ACTIB
ISOPROPYL ALCOHOL	ND2M416302	ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021555-001	CHLORAPREP ONE-STEP SEPP	CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL	2%;70% (0.67ML)	SWAB / TOPICAL	RLD, RS	2002-10-07
N021555-002	CHLORAPREP SINGLE SWABSTICK	CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL	2%;70% (1.75ML)	SWAB / TOPICAL	RLD, RS	2005-05-10
N021555-003	CHLORAPREP TRIPLE SWABSTICK	CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL	2%;70% (5.25ML)	SWAB / TOPICAL	RLD, RS	2009-06-10

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021555-001	CHLORAPREP ONE-STEP SEPP	2%;70% (0.67ML)	SWAB / TOPICAL	RLD, RS	2002-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021555-002	CHLORAPREP SINGLE SWABSTICK	2%;70% (1.75ML)	SWAB / TOPICAL	RLD, RS	2005-05-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021555-003	CHLORAPREP TRIPLE SWABSTICK	2%;70% (5.25ML)	SWAB / TOPICAL	RLD, RS	2009-06-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021555-001	CHLORAPREP ONE-STEP SEPP	2%;70% (0.67ML)	SWAB / TOPICAL	RLD, RS	2002-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021555-002	CHLORAPREP SINGLE SWABSTICK	2%;70% (1.75ML)	SWAB / TOPICAL	RLD, RS	2005-05-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021555-003	CHLORAPREP TRIPLE SWABSTICK	2%;70% (5.25ML)	SWAB / TOPICAL	RLD, RS	2009-06-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021555-001	CHLORAPREP ONE-STEP SEPP	2%;70% (0.67ML)	SWAB / TOPICAL	RLD, RS	2002-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021555-002	CHLORAPREP SINGLE SWABSTICK	2%;70% (1.75ML)	SWAB / TOPICAL	RLD, RS	2005-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021555-003	CHLORAPREP TRIPLE SWABSTICK	2%;70% (5.25ML)	SWAB / TOPICAL	RLD, RS	2009-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021555-001	CHLORAPREP ONE-STEP SEPP	2%;70% (0.67ML)	SWAB / TOPICAL	RLD, RS	2002-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021555-002	CHLORAPREP SINGLE SWABSTICK	2%;70% (1.75ML)	SWAB / TOPICAL	RLD, RS	2005-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021555-003	CHLORAPREP TRIPLE SWABSTICK	2%;70% (5.25ML)	SWAB / TOPICAL	RLD, RS	2009-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021555-001	CHLORAPREP ONE-STEP SEPP	2%;70% (0.67ML)	SWAB / TOPICAL	RLD, RS	2002-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021555-002	CHLORAPREP SINGLE SWABSTICK	2%;70% (1.75ML)	SWAB / TOPICAL	RLD, RS	2005-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021555-003	CHLORAPREP TRIPLE SWABSTICK	2%;70% (5.25ML)	SWAB / TOPICAL	RLD, RS	2009-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021555-001	CHLORAPREP ONE-STEP SEPP	2%;70% (0.67ML)	SWAB / TOPICAL	RLD, RS	2002-10-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021555-002	CHLORAPREP SINGLE SWABSTICK	2%;70% (1.75ML)	SWAB / TOPICAL	RLD, RS	2005-05-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021555-003	CHLORAPREP TRIPLE SWABSTICK	2%;70% (5.25ML)	SWAB / TOPICAL	RLD, RS	2009-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021555-001	CHLORAPREP ONE-STEP SEPP	2%;70% (0.67ML)	SWAB / TOPICAL	RLD, RS	2002-10-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021555-002	CHLORAPREP SINGLE SWABSTICK	2%;70% (1.75ML)	SWAB / TOPICAL	RLD, RS	2005-05-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021555-003	CHLORAPREP TRIPLE SWABSTICK	2%;70% (5.25ML)	SWAB / TOPICAL	RLD, RS	2009-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021555-001	CHLORAPREP ONE-STEP SEPP	2%;70% (0.67ML)	SWAB / TOPICAL	RLD, RS	2002-10-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021555-002	CHLORAPREP SINGLE SWABSTICK	2%;70% (1.75ML)	SWAB / TOPICAL	RLD, RS	2005-05-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021555-003	CHLORAPREP TRIPLE SWABSTICK	2%;70% (5.25ML)	SWAB / TOPICAL	RLD, RS	2009-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021555-001	CHLORAPREP ONE-STEP SEPP	2%;70% (0.67ML)	SWAB / TOPICAL	RLD, RS	2002-10-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021555-002	CHLORAPREP SINGLE SWABSTICK	2%;70% (1.75ML)	SWAB / TOPICAL	RLD, RS	2005-05-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021555-003	CHLORAPREP TRIPLE SWABSTICK	2%;70% (5.25ML)	SWAB / TOPICAL	RLD, RS	2009-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021555-001	CHLORAPREP ONE-STEP SEPP	2%;70% (0.67ML)	SWAB / TOPICAL	RLD, RS	2002-10-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021555-002	CHLORAPREP SINGLE SWABSTICK	2%;70% (1.75ML)	SWAB / TOPICAL	RLD, RS	2005-05-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021555-003	CHLORAPREP TRIPLE SWABSTICK	2%;70% (5.25ML)	SWAB / TOPICAL	RLD, RS	2009-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021555-001	CHLORAPREP ONE-STEP SEPP	2%;70% (0.67ML)	SWAB / TOPICAL	RLD, RS	2002-10-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021555-002	CHLORAPREP SINGLE SWABSTICK	2%;70% (1.75ML)	SWAB / TOPICAL	RLD, RS	2005-05-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021555-003	CHLORAPREP TRIPLE SWABSTICK	2%;70% (5.25ML)	SWAB / TOPICAL	RLD, RS	2009-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021555-001	CHLORAPREP ONE-STEP SEPP	2%;70% (0.67ML)	SWAB / TOPICAL	RLD, RS	2002-10-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021555-002	CHLORAPREP SINGLE SWABSTICK	2%;70% (1.75ML)	SWAB / TOPICAL	RLD, RS	2005-05-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021555-003	CHLORAPREP TRIPLE SWABSTICK	2%;70% (5.25ML)	SWAB / TOPICAL	RLD, RS	2009-06-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021555-001	CHLORAPREP ONE-STEP SEPP	2%;70% (0.67ML)	SWAB / TOPICAL	RLD, RS	2002-10-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021555-002	CHLORAPREP SINGLE SWABSTICK	2%;70% (1.75ML)	SWAB / TOPICAL	RLD, RS	2005-05-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021555-003	CHLORAPREP TRIPLE SWABSTICK	2%;70% (5.25ML)	SWAB / TOPICAL	RLD, RS	2009-06-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021555-001	CHLORAPREP ONE-STEP SEPP	2%;70% (0.67ML)	SWAB / TOPICAL	RLD, RS	2002-10-07	`301d65b070ca…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ChloraPrep One-Step	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	CareFusion 213, LLC	85291b2b-40b9-07fa-e053-2a91aa0a84e4	2025-11-04	Warnings	Exact identifier ndc (product): 54365-400
ChloraPrep One-Step	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	CareFusion 213, LLC	85416361-90b5-3efa-e053-2a91aa0af431	2025-11-03	Warnings	Exact identifier ndc (product): 54365-400
ChloraPrep One-Step	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	CareFusion 213, LLC	8528a4f5-5ff4-45f3-e053-2991aa0a804c	2025-11-03	Warnings	Exact identifier ndc (product): 54365-400
ChloraPrep One-Step	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	CareFusion 213, LLC	8529596f-37e4-c44e-e053-2a91aa0ad014	2025-10-30	Warnings	Exact identifier ndc (product): 54365-400
ChloraPrep One-Step	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	CareFusion 213, LLC	8578da30-a155-2505-e053-2991aa0a2c04	2025-10-29	Warnings	Exact identifier ndc (product): 54365-400
ChloraPrep One-Step	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	CareFusion 213, LLC	8541f219-c060-399a-e053-2991aa0ab05c	2025-10-24	Warnings	Exact identifier ndc (product): 54365-400
ChloraPrep One-Step	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	CareFusion 213, LLC	8541a1ed-2a92-1fab-e053-2a91aa0a29d1	2025-10-23	Warnings	Exact identifier ndc (product): 54365-400
ChloraPrep One-Step	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	CareFusion 213, LLC	85790749-5a95-7f18-e053-2a91aa0a1a02	2025-10-17	Warnings	Exact identifier ndc (product): 54365-400
ChloraPrep One-Step	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	CareFusion 213, LLC	85791e13-4103-19fe-e053-2991aa0a647f	2025-10-17	Warnings	Exact identifier ndc (product): 54365-400
ChloraPrep One-Step	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	CareFusion 213, LLC	85794f6b-d1ea-40f9-e053-2991aa0a8823	2025-10-17	Warnings	Exact identifier ndc (product): 54365-400
ChloraPrep One-Step	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	CareFusion 213 LLC	f06e4f9d-6cef-b57a-e053-2a95a90a7337	2025-07-03	Warnings	Exact identifier ndc (product): 54365-400
292b4ddf-f5d5-d052-e063-6394a90a5f1d			044e24de-c76b-0161-e054-00144ff8d46c	2024-12-13	Warnings	Exact identifier spl id: 292b4ddf-f5d5-d052-e063-6394a90a5f1d spl set id: 044e24de-c76b-0161-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.