Dyna-Hex 2

Manufacturer
Xttrium Laboratories, Inc.
Effective date
2020-10-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:31:31

Label at a glance#

ProductDyna-Hex 2
Active ingredientCHLORHEXIDINE GLUCONATE
Label structure12 sections

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 skin wound and general skin cleansing

Dosage and administration

Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. wet hands and forearms under running water for 30 seconds. Clean fingernails using a nailstick or similar cleaner. scrub for 1.5 minutes with 8 mL of product (6 full pumps) with or without a wet brush paying close attention to the nails, cuticles, and skin between the fingers rinse thoroughly...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

chlorhexidine gluconate 2% solution

Purpose

OTC - PURPOSE SECTION

antiseptic

Uses

INDICATIONS & USAGE SECTION

  • 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
  • skin wound and general skin cleansing

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
  • in contact with meninges
  • in the genital area

When using this product

OTC - WHEN USING SECTION

  • 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
  • repeated general skin cleansing of large body areas should not be done except when advised by a health care provider

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.

Surgical hand scrub:

SPL UNCLASSIFIED SECTION

  • wet hands and forearms under running water for 30 seconds. Clean fingernails using a nailstick or similar cleaner.
  • scrub for 1.5 minutes with 8 mL of product (6 full pumps) with or without a wet brush paying close attention to the nails, cuticles, and skin between the fingers
  • rinse thoroughly under running water for 30 seconds
  • wash for an additional 1.5 minutes with 8 mL of product (6 full pumps) and rinse under running water for 30 seconds
  • dry thoroughly

Healthcare personnel handwash:

SPL UNCLASSIFIED SECTION

  • wet hands with water
  • dispense 5 mL of product (4 full pumps) into cupped hands and wash in a vigorous manner for 15 seconds
  • rinse and dry thoroughly

Skin wound and general skin cleansing:

SPL UNCLASSIFIED SECTION

  • 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 information

SPL UNCLASSIFIED SECTION

  • store at 20-25° C (68-77° F)
  • avoid excessive heat above 40° C (104° F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

Questions or comments?

OTC - QUESTIONS SECTION

call 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST

RECENT MAJOR CHANGES SECTION

  • Indications and Usage

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0116-1022-18

DYNA-HEX 2®

Chlorhexidine Gluconate 2% Solution

Antiseptic

Contains: 2% Chlorhexidine Gluconate With Foaming Pump

Distributed By: Xttrium Laboratories, Inc. Mount Prospect, IL 60056

FOR EXTERNAL USE ONLY

Net Contents: 18 fl oz (532 mL)

2DYN18BTLLBLA

2DYN18 PDP2DYN18 PDP

2DYN18 DF12DYN18 DF1

2DYN18 DF22DYN18 DF2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1245230chlorhexidine gluconate 2 % Medicated Liquid SoapPSN3
834160DYNA-HEX 2 2 % Medicated Liquid SoapPSN3
834160chlorhexidine gluconate 20 MG/ML Medicated Liquid Soap [Dyna-Hex]SBD3
1245230chlorhexidine gluconate 20 MG/ML Medicated Liquid SoapSCD3
1245230chlorhexidine gluconate 2 % Medicated Liquid SoapSY3
834160Dyna-Hex 2 % Medicated Liquid SoapSY3
834160Dyna-Hex 20 MG/ML Medicated Liquid SoapSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORHEXIDINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0116-1022-18Dyna-Hex 2535 mL in 1 BOTTLESOLUTION5353

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0116-1022DYNA-HEX 2 (CHLORHEXIDINE GLUCONATE 2%) SOLUTION [XTTRIUM LABORATORIES, INC.]3Current NDC, Legacy NDC, 1 package rows20201014_36e6abcb-d792-3ef4-e054-00144ff8d46c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0116-10220116-1022-18

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019422-001DYNA-HEX 2CHLORHEXIDINE GLUCONATE2%SOLUTION / TOPICALRLD, RS1985-12-17

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N019422-001DYNA-HEX 22%SOLUTION / TOPICALRLD, RS1985-12-1784e616aacf4f…
2026-08-18 06:07:402026-07N019422-001DYNA-HEX 22%SOLUTION / TOPICALRLD, RS1985-12-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-1787673890dc5c…
2021-03-12 10:30 UTC2021-03N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-173f01610625f2…
2019-09-15 20:21 UTC2019-09N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17b00525d2431f…
2019-07-19 19:46 UTC2019-07N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-173f0d92c62455…
2023-05-13 08:27 UTC2023-05N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17053a50430f4f…
2023-01-26 05:58 UTC2023-01N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17f41ea6bd6efb…

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.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dyna-Hex 2CHLORHEXIDINE GLUCONATE 2%Xttrium Laboratories, Inc.0c808ebd-1bf7-175d-e063-6294a90ae7df2025-04-30WarningsExact identifier
ndc (product): 0116-1022
Dyna-Hex 2CHLORHEXIDINE GLUCONATE 2%Xttrium Laboratories, Inc.36e6abcb-d792-3ef4-e054-00144ff8d46c2020-10-13WarningsExact identifier
ndc (package): 0116-1022-18
ndc (product): 0116-1022
ndc11 (package): 00116102218
spl id: b18f1e18-04d5-ef27-e053-2995a90a7b09
spl set id: 36e6abcb-d792-3ef4-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.