Storage and handling
Other information • store between 15-30 °C (59-86 °F) • avoid freezing and excessive heat above 40 °C (104 °F) • the tint will slowly fade from the skin. Soap and water, or alcohol may be used to remove the tint if desired.
Other information • store between 15-30 °C (59-86 °F) • avoid freezing and excessive heat above 40 °C (104 °F) • the tint will slowly fade from the skin. Soap and water, or alcohol may be used to remove the tint if desired.
CHLORAPREP ONE-STEP (chlorhexidine gluconate and isopropyl aclohol) solution
[CareFusion 213 LLC]
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
Do not use
•
on patients with known allergies to chlorhexidine gluconate or isopropyl alcohol
•
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 cm2)
•
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 30 seconds
•
moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes for 2 minutes
•
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)
•
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
Package Label Display Panel
Package Label Display Panel
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 998282 | ChloraPrep 2 % / 70 % Topical Solution | PSN | 1 |
| 858726 | chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Solution | PSN | 1 |
| 998282 | chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Topical Solution [ChloraPrep] | SBD | 1 |
| 858726 | chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Topical Solution | SCD | 1 |
| 998282 | ChloraPrep (chlorhexidine gluconate 2 % / isopropyl alcohol 70 % ) Topical Solution | SY | 1 |
| 858726 | chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Solution | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| CHLORHEXIDINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| bb6d6c68-649d-4e6d-a1f6-603d969c8f68 | Product name | 1 | 20160303 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54365-400-11 | ACL11CH NERVE BLOCK | 3 mL in 1 APPLICATOR | SOLUTION | 3 mL | 20 mg in 1mL | 1 |
| 55553-482-02 | ACL11CH NERVE BLOCK | 1 in 1 PACKAGE, COMBINATION | KIT | 1 | 1 | |
| 55553-482-02 | ACL11CH NERVE BLOCK | 30 in 1 CASE | KIT | 30 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 54365-400 | ACL11CH NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.] | 1 | Current NDC, Legacy NDC | 20140415_57a2935b-5741-43ce-9833-1de31eb02011.zip |
| 55553-482 | ACL11CH NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.] | 1 | 3 package rows | 20140415_57a2935b-5741-43ce-9833-1de31eb02011.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| CHLORHEXIDINE GLUCONATE | ACTIVE INGREDIENT | MOR84MUD8E | 1 | |
| ISOPROPYL ALCOHOL | ACTIVE INGREDIENT | ND2M416302 | 1 | |
| CHLORHEXIDINE | ACTIVE MOIETY | R4KO0DY52L | 1 | |
| ISOPROPYL ALCOHOL | ACTIVE MOIETY | ND2M416302 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 55553-482 | 55553-482-02 |
| 54365-400 | 54365-400-11 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CHLORHEXIDINE GLUCONATE | MOR84MUD8E | ACTIB |
| WATER | 059QF0KO0R | IACT |
| ISOPROPYL ALCOHOL | ND2M416302 | ACTIB |
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.