ChloraPrep One-Step

Manufacturer
CareFusion 213 LLC | Becton, Dickinson and Company
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
20
Source
legacy-cache
Hydrated at
2026-08-01 20:46:36

Label at a glance#

ProductChloraPrep One-Step
Active ingredientCHLORHEXIDINE GLUCONATE, ISOPROPYL ALCOHOL
Label structure10 sections

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 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 applica...

Storage and handling

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

Label contents#

Full prescribing information#

WARNING. FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME

WARNINGS AND PRECAUTIONS SECTION

Keep away from fire or flame.

To reduce 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. × 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

OTC - ACTIVE INGREDIENT SECTION

Chlorhexidine gluconate 2% w/v

Isopropyl alcohol 70% v/v

Purposes

OTC - PURPOSE SECTION

Antiseptic

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. 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 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:

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

OTC - DO NOT USE SECTION

  • on patients allergic to chlorhexidine gluconate or any other ingredient in this product
  • for lumbar puncture or in contact with the meningea
  • on open skin wounds or as a general skin cleanser

When using this product

OTC - WHEN USING 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

OTC - ASK DOCTOR 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 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 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

STORAGE AND HANDLING SECTION

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

Inactive ingredient

INACTIVE INGREDIENT SECTION

USP purified water

Questions?

OTC - QUESTIONS SECTION

Package Label: 26mL Applicators Non-Sterile Solution: Clear, Hi-Lite Orange, Scrub Teal

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ChloraPrep 26 ml ClearChloraPrep 26 ml Clear

54365-400-1354365-400-13

54365-400-0554365-400-05

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CHLORHEXIDINE GLUCONATEACTIVE INGREDIENTMOR84MUD8E11
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M41630211
CHLORHEXIDINEACTIVE MOIETYR4KO0DY52L11
ISOPROPYL ALCOHOLACTIVE MOIETYND2M41630211
WATERINACTIVE INGREDIENT059QF0KO0R11

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54365-40054365-400-14, 54365-400-13, 54365-400-05

Ingredients#

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

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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021555-001CHLORAPREP ONE-STEP SEPPCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-07
N021555-002CHLORAPREP SINGLE SWABSTICKCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-10
N021555-003CHLORAPREP TRIPLE SWABSTICKCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-10

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-0784e616aacf4f…
2026-09-14 22:38:342026-08N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-1084e616aacf4f…
2026-09-14 22:38:342026-08N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-1084e616aacf4f…
2026-08-18 06:07:402026-07N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-07caaa826d4ba7…
2026-08-18 06:07:402026-07N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-10caaa826d4ba7…
2026-08-18 06:07:402026-07N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-07d06236e962d9…
2024-10-29 15:01 UTC2024-10N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-10d06236e962d9…
2024-10-29 15:01 UTC2024-10N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-07301d65b070ca…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC85291b2b-40b9-07fa-e053-2a91aa0a84e42025-11-04WarningsExact identifier
ndc (product): 54365-400
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC85416361-90b5-3efa-e053-2a91aa0af4312025-11-03WarningsExact identifier
ndc (product): 54365-400
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC8528a4f5-5ff4-45f3-e053-2991aa0a804c2025-11-03WarningsExact identifier
ndc (product): 54365-400
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC8529596f-37e4-c44e-e053-2a91aa0ad0142025-10-30WarningsExact identifier
ndc (product): 54365-400
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC8578da30-a155-2505-e053-2991aa0a2c042025-10-29WarningsExact identifier
ndc (product): 54365-400
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC8541f219-c060-399a-e053-2991aa0ab05c2025-10-24WarningsExact identifier
ndc (product): 54365-400
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC8541a1ed-2a92-1fab-e053-2a91aa0a29d12025-10-23WarningsExact identifier
ndc (product): 54365-400
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC85790749-5a95-7f18-e053-2a91aa0a1a022025-10-17WarningsExact identifier
ndc (product): 54365-400
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC85791e13-4103-19fe-e053-2991aa0a647f2025-10-17WarningsExact identifier
ndc (product): 54365-400
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC85794f6b-d1ea-40f9-e053-2991aa0a88232025-10-17WarningsExact identifier
ndc (product): 54365-400
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213 LLCf06e4f9d-6cef-b57a-e053-2a95a90a73372025-07-03WarningsExact identifier
ndc (product): 54365-400
292bbbca-5409-eb19-e063-6394a90a4251adf7e698-bfbb-49b8-961e-dde1b2d34fb62024-12-13WarningsExact identifier
spl id: 292bbbca-5409-eb19-e063-6394a90a4251
spl set id: adf7e698-bfbb-49b8-961e-dde1b2d34fb6

Reported adverse events (FAERS/openFDA)#

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