Storage and handling
Other information store between 15-30 °C (59-86 °F) avoid freezing and excessive heat above 40 °C (104 °F)
Other information store between 15-30 °C (59-86 °F) avoid freezing and excessive heat above 40 °C (104 °F)
CHLORAPREP ONE-STEP (chlorhexidine gluconate and
isopropyl aclohol) solution
[CareFusion 213 LLC]
Chlorhexidine gluconate 2% w/v
Isopropyl alcohol 70% v/v
Antiseptic
Antiseptic
Usefor the preparation of the patient's skin prior to surgery: Helps to reduce bacterial that potentially can cause skin infection.
For external use only.
Flammable, keep away from fire or flame. To reduce the risk of fire, PREP CAREFULLY:
If swallowed, get medical help or contact a Poison Control Center right away.
NDC 054365-400-11
3ml APPLICATORS
Hi-Lite Orange®
Single Use
Latex Free
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)
25 applicators
0.10 fl. oz. (3 ml) each
ChloraPrep® With Tint
2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol
Patient Preoperative Skin Preparation
WARNING FLAMMABLE
Keep away from fire or flame.
To reduce risk of fire, PREP CAREFULLY:

A3632 PORTEX NERVE BLOCK
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| CHLORHEXIDINE GLUCONATE | ACTIVE INGREDIENT | MOR84MUD8E | 2 | |
| ISOPROPYL ALCOHOL | ACTIVE INGREDIENT | ND2M416302 | 2 | |
| CHLORHEXIDINE | ACTIVE MOIETY | R4KO0DY52L | 2 | |
| ISOPROPYL ALCOHOL | ACTIVE MOIETY | ND2M416302 | 2 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 51688-6025 | 51688-6025-2 |
| 54365-400 | 54365-400-11 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CHLORHEXIDINE GLUCONATE | MOR84MUD8E | ACTIB |
| ISOPROPYL ALCOHOL | ND2M416302 | ACTIB |
| WATER | 059QF0KO0R | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | GEL / TOPICAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SOLUTION / RECTAL | 0.5 %w/v | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SOLUTION / ORAL | 75.3 mg/15ml | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | LOTION / TOPICAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SOAP / TOPICAL | 0.2 %w/w | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SPONGE / TOPICAL | 0.01 %w/w | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SOLUTION / ORAL | 75.3 mg/15ml | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SOAP / TOPICAL | 0.2 %w/w | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | LOTION / TOPICAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SOLUTION / RECTAL | 0.5 %w/v | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | GEL / TOPICAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SPONGE / TOPICAL | 0.01 %w/w |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | 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 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N021555-001 | CHLORAPREP ONE-STEP SEPP | 2%;70% (0.67ML) | SWAB / TOPICAL | RLD, RS | 2002-10-07 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N021555-002 | CHLORAPREP SINGLE SWABSTICK | 2%;70% (1.75ML) | SWAB / TOPICAL | RLD, RS | 2005-05-10 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N021555-003 | CHLORAPREP TRIPLE SWABSTICK | 2%;70% (5.25ML) | SWAB / TOPICAL | RLD, RS | 2009-06-10 | c2088c7a36db… | |
| 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… |
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.
| 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 | 54365-400 |
| ChloraPrep One-Step | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL | CareFusion 213, LLC | 85416361-90b5-3efa-e053-2a91aa0af431 | 2025-11-03 | Warnings | 54365-400 |
| ChloraPrep One-Step | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL | CareFusion 213, LLC | 8528a4f5-5ff4-45f3-e053-2991aa0a804c | 2025-11-03 | Warnings | 54365-400 |
| ChloraPrep One-Step | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL | CareFusion 213, LLC | 8529596f-37e4-c44e-e053-2a91aa0ad014 | 2025-10-30 | Warnings | 54365-400 |
| ChloraPrep One-Step | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL | CareFusion 213, LLC | 8578da30-a155-2505-e053-2991aa0a2c04 | 2025-10-29 | Warnings | 54365-400 |
| ChloraPrep One-Step | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL | CareFusion 213, LLC | 8541f219-c060-399a-e053-2991aa0ab05c | 2025-10-24 | Warnings | 54365-400 |
| ChloraPrep One-Step | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL | CareFusion 213, LLC | 8541a1ed-2a92-1fab-e053-2a91aa0a29d1 | 2025-10-23 | Warnings | 54365-400 |
| ChloraPrep One-Step | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL | CareFusion 213, LLC | 85790749-5a95-7f18-e053-2a91aa0a1a02 | 2025-10-17 | Warnings | 54365-400 |
| ChloraPrep One-Step | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL | CareFusion 213, LLC | 85791e13-4103-19fe-e053-2991aa0a647f | 2025-10-17 | Warnings | 54365-400 |
| ChloraPrep One-Step | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL | CareFusion 213, LLC | 85794f6b-d1ea-40f9-e053-2991aa0a8823 | 2025-10-17 | Warnings | 54365-400 |
| ChloraPrep One-Step | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL | CareFusion 213 LLC | f06e4f9d-6cef-b57a-e053-2a95a90a7337 | 2025-07-03 | Warnings | 54365-400 |
Adverse event summaries are temporarily unavailable. Other product information remains available.