CHLORHEXIDINE GLUCONATE
- Manufacturer
- McKesson | XTTRIUM LABORATORIES, INC.
- Effective date
- 2025-12-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- full-release
- Hydrated at
- 2026-06-01 01:27:15
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Chlorhexidine gluconate 4% solution
OTC - PURPOSE SECTION
Purpose
Antiseptic
INDICATIONS & USAGE SECTION
Uses
- Surgical hand scrub:significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care.
- Healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
- Patient preoperative skin preparation:for the preparation of the patient's skin prior to surgery skin wound and general skin cleansing
- Skin wound and general skin cleansing
WARNINGS SECTION
Warnings
For external use only
Allergy Alert
This product may cause a severe allergic reaction. Symptoms may include:
- wheezing/difficulty breathing
- shock
- facial swelling
- hives
- rash
WARNING: This product can expose you
to coconut oil diethanolamine
condensate (cocamide diethanolamine),
which is known to the State of California
to cause cancer. For more information
go to
www.P65Warnings.ca.gov.
OTC - STOP USE SECTION
If an allergic reaction occurs, stop use and seek medical help right away.
Do not use
- if you are allergic to chlorhexidine gluconate or any other ingredients in this product
- in contact with meninges
- in the genital area
- as a preoperative skin preparation of the head or face
When using this product
- keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardrums
- if solution should contact these areas, rinse out promptly and thoroughly with water
- wounds which involve more than the superficial layers of the skin should not be routinely treated
- repeated general skin cleansing of large body areas should not be done except when the underlying
condition makes it necessary to reduce the bacterial population of the skin
Stop use and ask doctor ifirritation, sensitization or allergic reaction occurs. These may be signs of a serious condition.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
- use with care in premature infants or infants under 2 months of age. These products may causeirritation or chemical burns.
Surgical hand s crub:
- wet hands and forearms with water
- scrub for 3 minutes with about 5 mL of product and a wet brush paying close attention to the nails, cuticles, and interdigital spaces
- a separate nail cleaner may be used
- rinse thoroughly
- wash for an additional 3 minutes with 5 mL of product and rinse under running water
- dry thoroughly
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 sterile towel
- repeat procedure for an additional 2 minutes and dry with a sterile towel
Skin wound and general skin cleaning:
- thoroughly rinse the area to be cleaned with water
- apply the minimum amount of product necessary to cover the skin or wound area and wash gently
- rinse again thoroughly
OTHER SAFETY INFORMATION
Other information
- store at 68-77ºF (20-25°C)
- avoid excessive heat above 104°F (40°C)
INACTIVE INGREDIENT SECTION
Inactive ingredients
cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine
oxide, PEG-75 lanolin, purified water, tridecyl alcohol
OTC - QUESTIONS SECTION
Questions?
General Questions? Call 1-800-777-4908
Technical Support? Call 1-800-587-3721
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 68599-5400-2
McKesson
Antiseptic Skin Cleanser
4% CHLORHEXIDINE GLUCONATE SOLUTION
A non-sterile solution that reduces the number of
microorganisms on the skin prior to surgery or patient care.
0.5 fl oz
(15 mL)
50
PER BOX
FOR SINGLE-USE
MFR # 16-CHG15
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CHLORHEXIDINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| bb6d6c68-649d-4e6d-a1f6-603d969c8f68 | Product name | 1 | 20160303 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68599-5400-1 | CHLORHEXIDINE GLUCONATE | 15 mL in 1 PACKET | GEL | 15 | 7 | |
| 68599-5400-2 | CHLORHEXIDINE GLUCONATE | 50 in 1 BOX | GEL | 50 | 7 | |
| 68599-5400-3 | CHLORHEXIDINE GLUCONATE | 10 in 1 CASE | GEL | 10 | 7 |
Products#
Every source-derived product name is available through these pages.
- CHLORHEXIDINE GLUCONATE
- ANTISEPTIC SKIN CLEANSER
- TRIDECYL ALCOHOL
- COCO DIETHANOLAMIDE
- PEG-75 LANOLIN
- GLUCONOLACTONE
- HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)
- LAURAMINE OXIDE
- WATER
- ISOPROPYL ALCOHOL
- CHLORHEXIDINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68599-5400 | 68599-5400-1, 68599-5400-2, 68599-5400-3 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TRIDECYL ALCOHOL | 8I9428H868 | IACT |
| COCO DIETHANOLAMIDE | 92005F972D | IACT |
| PEG-75 LANOLIN | 09179OX7TB | IACT |
| GLUCONOLACTONE | WQ29KQ9POT | IACT |
| HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) | R33S7TK2EP | IACT |
| LAURAMINE OXIDE | 4F6FC4MI8W | IACT |
| WATER | 059QF0KO0R | IACT |
| ISOPROPYL ALCOHOL | ND2M416302 | IACT |
| CHLORHEXIDINE GLUCONATE | MOR84MUD8E | ACTIB |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019125-001 | DYNA-HEX 4 | CHLORHEXIDINE GLUCONATE | 4% | SOLUTION / TOPICAL | 1984-12-24 |
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.
| 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 | N019125-001 | DYNA-HEX 4 | 4% | SOLUTION / TOPICAL | 1984-12-24 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019125-001 | DYNA-HEX 4 | 4% | SOLUTION / TOPICAL | 1984-12-24 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | f41ea6bd6efb… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 4651cabb-98e1-a257-e063-6294a90afd3b | 673abf62-7774-6af1-e053-2a91aa0afc52 | 2025-12-19 | Warnings | 4651cabb-98e1-a257-e063-6294a90afd3b 673abf62-7774-6af1-e053-2a91aa0afc52 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
