FDA.reportPublic FDA data

Hexatrione

Manufacturer
Medexus Pharma, Inc. | Fisiopharma SRL
Effective date
2026-09-15
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-09-19 01:02:58

Label at a glance#

ProductHexatrione 2%
Active ingredientTRIAMCINOLONE HEXACETONIDE
Label structure3 sections

Label contents#

Full prescribing information#

DHCP page 1

HEALTH CARE PROVIDER LETTER SECTION

DHCP page 1DHCP page 1

DHCP p2

HEALTH CARE PROVIDER LETTER SECTION

DHCP p2DHCP p2

DHCP p3

HEALTH CARE PROVIDER LETTER SECTION

DHCP p3DHCP p3

DHCP p4

HEALTH CARE PROVIDER LETTER SECTION

DHCP p4DHCP p4

DHCP p5

HEALTH CARE PROVIDER LETTER SECTION

DHCP p5DHCP p5

DHCP p6

HEALTH CARE PROVIDER LETTER SECTION

DHCP p6DHCP p6

DHCP p7

HEALTH CARE PROVIDER LETTER SECTION

DHCP p7DHCP p7

DHCP p8

HEALTH CARE PROVIDER LETTER SECTION

DHCP p8DHCP p8

DHCP p9

HEALTH CARE PROVIDER LETTER SECTION

DHCP p9DHCP p9

DHCP p10

HEALTH CARE PROVIDER LETTER SECTION

DHCP p10DHCP p10

DHCP p11

HEALTH CARE PROVIDER LETTER SECTION

DHCP p11DHCP p11

DHCP p12

HEALTH CARE PROVIDER LETTER SECTION

DHCP p12DHCP p12

DHCP p13

HEALTH CARE PROVIDER LETTER SECTION

DHCP p13DHCP p13

DHCP p14

HEALTH CARE PROVIDER LETTER SECTION

DHCP p14DHCP p14

DHCP p15

HEALTH CARE PROVIDER LETTER SECTION

DHCP p15DHCP p15

DHCP p16

HEALTH CARE PROVIDER LETTER SECTION

DHCP p16DHCP p16

DHCP p17

HEALTH CARE PROVIDER LETTER SECTION

DHCP p17DHCP p17

DHCP p18

HEALTH CARE PROVIDER LETTER SECTION

DHCP p18DHCP p18

DHCP p19

HEALTH CARE PROVIDER LETTER SECTION

DHCP p19DHCP p19

DHCP p20

HEALTH CARE PROVIDER LETTER SECTION

DHCP p20DHCP p20

DHCP p21

HEALTH CARE PROVIDER LETTER SECTION

DHCP p21DHCP p21

DHCP p22

HEALTH CARE PROVIDER LETTER SECTION

DHCP p22DHCP p22

DHCP p23

HEALTH CARE PROVIDER LETTER SECTION

DHCP p23DHCP p23

DHCP p24

HEALTH CARE PROVIDER LETTER SECTION

DHCP p24DHCP p24

DHCP p25

HEALTH CARE PROVIDER LETTER SECTION

DHCP p25DHCP p25

DHCP p26

HEALTH CARE PROVIDER LETTER SECTION

DHCP p26DHCP p26

DHCP p27

HEALTH CARE PROVIDER LETTER SECTION

DHCP p27DHCP p27

HOW SUPPLIED SECTION

NDC 59137-570-01

  • 2 mL single-dose ampoule (40 mg/2mL). One ampoule per carton.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

20 mg/mL (2 mL Ampoule) - Ampoule Label

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20 mg/mL (2 mL Ampoule) - Carton Label

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Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeDataBar Limited(01)10057513089005GTIN-14: 10057513089005
GTIN storage (14 digits): 10057513089005		Hexatrione DHCP_05-26-2026_Page_06.jpg
Data codeCode 1283400931841302Hexatrion Carton 54002B.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d4d7da1a-7fd4-628e-cdae-89e749b1c534Product name720260127
75f7e47b-8736-a182-fc44-22aca8d79689Product name220251211
62986c8d-91f1-b1ba-b5a3-8b54b75bb8c2Product name620250516
e42f429b-c4e5-0402-e1c5-730154df4060Product name420240205
38d4de13-64b3-4057-b91c-4b5126962341Product name120220516
089e0644-1ea8-8654-4113-39f960dd57d5Product name320210115
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
5331c9c8-f64b-11e6-ccf1-071c477fcb0bProduct name720190612
9f64e0dc-109c-9660-8e0e-91ec987b3817Product name620171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002fProduct name120171204
8de20f81-8411-4cf1-a8b2-03404ee56d01Product name320171109
a5f1a68c-0352-4f34-46a3-9b4eed239ed8Product name220160819
355b2224-0895-7135-83f5-d099a6a82a0aProduct name120140508
55be6b50-8cc0-f0f1-74a1-3416a91193aaProduct name120140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59137-570-01ML - Milliliter59137-5702b859005-c206-4d1c-b1ca-2248bc0ba53312021-12-08

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59137-57059137-570-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
TRIAMCINOLONE HEXACETONIDEI7GT1U99Y9ACTIB
SORBITOL SOLUTION 70%8KW3E207O2IACT
WATER059QF0KO0RIACT
HYDROCHLORIC ACIDQTT17582CBIACT
BENZYL ALCOHOLLKG8494WBHIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM HYDROXIDE55X04QC32IIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52026-05-26full-release2026-05-31 22:21:43
42026-01-28monthly-update2026-06-03 17:55:43

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5128fd5b-e866-907e-e063-6394a90ac4c9bc07ae9f-8a74-6bc8-e053-2995a90afc0d2026-05-26Exact identifier
spl set id: bc07ae9f-8a74-6bc8-e053-2995a90afc0d

Reported adverse events (FAERS/openFDA)#

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