OTC - ACTIVE INGREDIENT SECTION
Chlorhexidine gluconate (CHG), 2% w/v
and Isopropyl alcohol (IPA), 70% v/v
Chlorhexidine gluconate (CHG), 2% w/v
and Isopropyl alcohol (IPA), 70% v/v
Antiseptic
for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.
For external use only. Flammable, keep away from fire or flame.
do not use with electrocautery procedures
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.
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
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.
irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
If swallowed, get medical help or contact a Poison Control Center right away.
use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
maximal treatment area for one applicator
one single swabstick applicator is approximately 2.5 in. x 2.5 in. (42 cm 2)
tear pouch at side notch to reveal applicator handles. Do not touch foam applicator tip. Place foam flat side down on the treatment area.
completely wet the treatment area with antiseptic
dry surgical sites (e.g., abdomen or arm): use repeated back-and-forth strokes for 30 seconds. (When using the triple swabstick applicators, use each swabstick sequentially within the 30 seconds). Allow the area to air dry for approximately 30 seconds. Do not blot or wipe away.
moist surgical sites (e.g., inguinal fold): use repeated back-and-forth strokes for 2 minutes. (When using the triple swabstick applicators, use each swabstick sequentially within the 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.
USP purified water
store between 15-30 ºC (59-86 °F)
avoid freezing and excessive heat above 40 ºC (104 °F)
| Class | Version | Type | Effective |
|---|---|---|---|
| CHLORHEXIDINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | Data Matrix | (01)00351662167519(17)500101(21)279392414059(10)HF1234TESTING | GTIN-14: 00351662167519 GTIN-12: 351662167519 UPC-A: 351662167519 EAN-13: 0351662167519 GTIN storage (14 digits): 00351662167519 | 51662-1675-1 .jpg |
| 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 |
|---|---|---|---|---|---|---|
| 51662-1675-1 | CHLORAPREP | 1.75 mL in 1 APPLICATOR | SOLUTION | 1.75 | 1 | |
| 51662-1675-1 | CHLORAPREP | 1 in 1 POUCH | SOLUTION | 1 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 51662-1675 | 51662-1675-1 |
| 54365-401 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ISOPROPYL ALCOHOL | ND2M416302 | ACTIB |
| CHLORHEXIDINE GLUCONATE | MOR84MUD8E | ACTIB |
| WATER | 059QF0KO0R | IACT |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 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 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 | CHLORAPREP | HF Acquisition Co LLC, DBA HealthFirst | 44fe08e0-4e9c-8bd6-e063-6394a90a0e2b | 2025-12-02 | Warnings | 51662-1675-1 51662-1675 51662167501 44fe08e0-4e9d-8bd6-e063-6394a90a0e2b 44fe08e0-4e9c-8bd6-e063-6394a90a0e2b |
| ChloraPrep Swabstick | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL | CareFusion 213 LLC | 1666069b-38f6-bfde-e063-6394a90ad1b8 | 2025-10-17 | Warnings | 54365-401 |
Adverse event summaries are temporarily unavailable. Other product information remains available.