Indications and 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
Dyna-Hex 32oz Round & Sqaure Bottle
- Manufacturer
- Xttrium Laboratories, Inc.
- Effective date
- 2026-04-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 01:55:41
Label at a glance#
ProductDyna-Hex 4
Active ingredientCHLORHEXIDINE GLUCONATE
Label structure11 sections
Dosage and administration
use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. Surgical hand scrub: wet hands and forearms with water scrub for 3 minutes with about 2.0 cubic inches 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 scrub for an additional 3 ...
Storage and handling
store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient
Chlorhexidine gluconate 4% solution
Purpose
Antiseptic
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
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
If an allergic reaction occurs, stop use and seek medical help right away.
Do not use
- if you or the patient are allergic to chlorhexidine gluconate or any other ingredient in this product
When using this product
keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye 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
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.
Surgical hand scrub:
wet hands and forearms with water
scrub for 3 minutes with about 2.0 cubic inches 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
scrub for an additional 3 minutes with 2.0 cubic inches of product and rinse under running water
dry thoroughly
Healthcare personnel handwash:
wet hands with water
dispense about 1.5 cubic inches of product into cupped hands and wash in a vigorous manner for 15 seconds
rinse and dry thoroughly
Other Information
store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)
INACTIVE INGREDIENT SECTION
cocamide DEA, fragrance, glucono-delta-lactone, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol.
Questions or comments?
call 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST
OTHER SAFETY INFORMATION
To Install: Remove bottle cap and apply dispensing cap. Slide dispenser into bracket, inserting the open air inlet onto proper receptacle
Container is single use only. Discard when empty.
Laundering/Cleaning Instructions:
Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products, such as chlorine bleach. Rinse completely and use only non-chlorine detergents.
Principle Display Panel
NDC 0116-1060-32
DYNA-HEX 4®
Chlorhexidine Gluconate 4% Solution
Antiseptic
Contains: 4% Chlorhexidine Gluconate
Distributed By: Xttrium Laboratories, Inc. Mount Prospect, IL 60056
CHLORHEXIDINE GLUCONATE
Net Contents: 32 fl oz (1 qt) (946 mL)
4DYN32RNDLBL
NDC 0116-1060-33
DYNA-HEX 4®
Chlorhexidine Gluconate 4% Solution
Antiseptic
Contains: 4% Chlorhexidine Gluconate
Distributed By: Xttrium Laboratories, Inc. Mount Prospect, IL 60056
CHLORHEXIDINE GLUCONATE
Net Contents: 32 fl oz (1 qt) (946 mL)
4DYN32SQLBL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 211365 | chlorhexidine gluconate 4 % Medicated Liquid Soap | PSN | 4 |
| 834162 | DYNA-HEX 4 4 % Medicated Liquid Soap | PSN | 4 |
| 834162 | chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap [Dyna-Hex] | SBD | 4 |
| 211365 | chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap | SCD | 4 |
| 211365 | chlorhexidine gluconate 4 % Medicated Liquid Soap | SY | 4 |
| 211365 | chlorhexidine gluconate 4 % Medicated Surgical Scrub | SY | 4 |
| 834162 | Dyna-Hex 4 % Medicated Liquid Soap | SY | 4 |
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 |
|---|---|---|---|---|---|---|
| 0116-1060-32 | Dyna-Hex 4 | 946 mL in 1 BOTTLE, PLASTIC | LIQUID | 946 | 4 | |
| 0116-1060-33 | Dyna-Hex 4 | 946 mL in 1 BOTTLE, PLASTIC | LIQUID | 946 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0116-1060-18 | ML - Milliliter | 0116-1060 | e64401a6-a26b-4236-a170-a4909ee6a1bf | 1 | 2018-10-11 |
| 0116-1060-32 | ML - Milliliter | 0116-1060 | 29c0bba8-fb2a-4ed9-a077-ba532ec67851 | 1 | 2024-11-05 |
Products#
Every source-derived product name is available through these pages.
- Dyna-Hex 4
- Chlorhexidine Gluconate
- PEG-75 LANOLIN
- ISOPROPYL ALCOHOL
- GLUCONOLACTONE
- WATER
- CHLORHEXIDINE
- LAURAMINE OXIDE
- TRIDECYL ALCOHOL
- COCO DIETHANOLAMIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0116-1060 | 0116-1060-32, 0116-1060-33 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PEG-75 LANOLIN | 09179OX7TB | IACT |
| ISOPROPYL ALCOHOL | ND2M416302 | IACT |
| GLUCONOLACTONE | WQ29KQ9POT | IACT |
| WATER | 059QF0KO0R | IACT |
| CHLORHEXIDINE GLUCONATE | MOR84MUD8E | ACTIB |
| LAURAMINE OXIDE | 4F6FC4MI8W | IACT |
| TRIDECYL ALCOHOL | 8I9428H868 | IACT |
| COCO DIETHANOLAMIDE | 92005F972D | IACT |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N019125-001 | DYNA-HEX 4 | 4% | SOLUTION / TOPICAL | 1984-12-24 | c2088c7a36db… | ||
| 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… |
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 |
|---|---|---|---|---|---|---|
| Dyna-Hex 4 | CHLORHEXIDINE GLUCONATE | Xttrium Laboratories, Inc. | 0a32c299-f7ca-d15c-e063-6294a90af2c1 | 2026-04-30 | Warnings | 0116-1060-32 0116-1060-33 0116-1060 00116106033 00116106032 50b0c122-cb50-3a71-e063-6294a90a5497 0a32c299-f7ca-d15c-e063-6294a90af2c1 |
| DYNA-HEX 4 | CHLORHEXIDINE GLUCONATE | Xttrium Laboratories, Inc. | 245c41e6-a0f6-0825-e054-00144ff8d46c | 2023-11-09 | Warnings | 0116-1060 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.