Indications and uses
healthcare personnel handwash: helps reduce bacteria that potentially can cause disease patient preoperative skin preparation: preparation of the patient's skin prior to surgery skin wound and skin cleansing
healthcare personnel handwash: helps reduce bacteria that potentially can cause disease patient preoperative skin preparation: preparation of the patient's skin prior to surgery skin wound and skin cleansing
use with care in premature infants under 2 months of age. These products may cause irritation or chemical burns. Healthcare personnel handwash: wet hands with water dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 15 seconds rinse and dry thoroughly Patient preoperative skin preparation: apply product liberally to surgical site and swab for at least 2 minutes and dry with a steril...
Drug Facts
Chlorhexidine Gluconate 2% Solution
Antiseptic
For external use only
Allergy alert:
This product may cause a severe allergic reaction. Symptoms may include:
if an allergic reaction occurs, stop use and seek medical help right awau
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
Healthcare personnel handwash:
Patient preoperative skin preparation:
Skin wound and general skin cleaning:
citric acid, cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water
call 1-800-587-3721
Monday through Friday 8:00 AM to 4:30 PM CST
Directions and Uses updated
NDA 0116-1021-04
DYNA-HEX 2 ®
(Chlorhexidine Gluconate 2% Solution)
Antiseptic
Contains: 2% Chlorhexidine Gluconate
FOR EXTERNAL USE ONLY
For single-use
Net Contents: 4 fl oz (118 mL)
Distributed By:
Xttrium Laboratories, Inc.
Mount Prospect, IL 60056
2BLDY04BTLLBLF
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0116-1021-04 | ML - Milliliter | 0116-1021 | 620183db-4ad8-4631-aba0-2969edd1518d | 1 | 2024-08-12 |
| 0116-1021-16 | ML - Milliliter | 0116-1021 | 99dae371-2187-4f0b-85e8-52df57a4376a | 1 | 2024-04-05 |
| 0116-1021-17 | ML - Milliliter | 0116-1021 | e6e690bb-da83-437f-95dc-63d2c7750941 | 1 | 2024-04-05 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 83062-021 | 83062-021-04 |
| 0116-1021 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | S38J6RZN16 | IACT |
| ISOPROPYL ALCOHOL | ND2M416302 | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| COCO DIETHANOLAMIDE | 92005F972D | IACT |
| LAURAMINE OXIDE | 4F6FC4MI8W | IACT |
| WATER | 059QF0KO0R | IACT |
| CHLORHEXIDINE GLUCONATE | MOR84MUD8E | 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 |
|---|---|---|---|---|---|---|---|
| N019422-001 | DYNA-HEX 2 | CHLORHEXIDINE GLUCONATE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 |
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 | N019422-001 | DYNA-HEX 2 | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N019422-001 | DYNA-HEX 2 | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N019422-001 | EXIDINE | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| DYNA-HEX 2 | CHLORHEXIDINE GLUCONATE | Xttrium Laboratories, Inc. | 6cc89ac1-baef-40bb-85a3-d9ae9e3e7a63 | 2026-04-27 | Warnings | 0116-1021 |
| DYNA-HEX 2 | CHLORHEXIDINE GLUCONATE | Xttrium Laboratories, Inc. | 6e5f9616-ddf5-19c4-e053-2991aa0a372a | 2025-04-30 | Warnings | 0116-1021 |
| 125f770f-2d30-ac5c-e063-6294a90a27b0 | 125f753b-a94a-e7e9-e063-6394a90a72ad | 2024-02-27 | Warnings | 125f770f-2d30-ac5c-e063-6294a90a27b0 125f753b-a94a-e7e9-e063-6394a90a72ad |
Adverse event summaries are temporarily unavailable. Other product information remains available.