FDA.reportPublic FDA data

Vexasyn Gel Prescription Only | Rx Only

Manufacturer
Sterling-Knight Pharmaceuticals, LLC
Effective date
2018-07-31
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 20:26:07

Label at a glance#

ProductVexasyn
Label structure11 sections

Dosage and administration

Cleanse wound then apply Vexasyn to the wound and skin surrounding the wound 3 - 4 times daily.

Storage and handling

Store at 25°C (77°F): excursions permitted to 15°-30°C (59°-86°F). Protect from freezing [See USP Controlled Room Temperature].

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Vexasyn is a soothing wound gel that promotes a moist wound environment that is ideal for the healing process.

Directions:

SPL UNCLASSIFIED SECTION

Cleanse wound then apply Vexasyn to the wound and skin surrounding the wound 3 - 4 times daily.

Indications:

INDICATIONS & USAGE SECTION

For the local management of painful skin wounds, including:
• Pressure ulcers
• Venus stasis ulcers
• Superficial wounds and scrapes
• 1st and 2nd degree burns

Warnings:

WARNINGS SECTION

External use only. Do not use this product if you are allergic to any of the ingredients. Avoid contact with eyes. Sterile unless opened or damaged.

Caution:

PRECAUTIONS SECTION

Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.

Storage:

STORAGE AND HANDLING SECTION

Store at 25°C (77°F): excursions permitted to 15°-30°C (59°-86°F). Protect from freezing [See USP Controlled Room Temperature].

Ingredients:

SPL UNCLASSIFIED SECTION

Ingredients: Water, Lidocaine HCl, Collagen, Aloe Vera gel, Sodium alginate, Glycerin, Hydroxyethylcellulose, Triethanolamine, Benzethonium chloride.

SPL UNCLASSIFIED SECTION

CALL YOUR DOCTOR ABOUT SIDE EFFECTS.
Call your doctor about side effects. You may report side effects to Sterling Knight Pharmaceuticals, LLC at 1-888-460-1531 or the FDA at 1-800-FDA-1088.

How Supplied

HOW SUPPLIED SECTION

Vexasyn wound gel is supplied as a gel in:
1 oz. (28.33g) tube, NDC 69336-831-01

SPL UNCLASSIFIED SECTION

Distributed By:
Sterling-Knight Pharmaceuticals, LLC
Ripley, MS 38663


Rev 121517-1

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

vexaimagevexaimage

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130369336813013GTIN-13: 0369336813013
EAN-13: 0369336813013
GTIN-12: 369336813013
UPC-A: 369336813013
GTIN storage (14 digits): 00369336813013		vaxasyn.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69336-831-012020-01-31C16284748780-19d75b9d1-1269-f424-e053-dadaa90a57ceVexasyn Gel Prescription Only | Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69336-831-01Vexasyn28.33 g in 1 BOTTLE28.333

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69336-831VEXASYN () [STERLING-KNIGHT PHARMACEUTICALS, LLC]31 package rows20180731_741d022f-954f-4686-b60e-08337235e9a7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69336-831-01GM - Gram69336-831379d47a1-6c87-43d9-bf3d-3ed5e499f9ad12018-09-05

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
69336-83169336-831-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AIACT
SODIUM ALGINATEC269C4G2ZQIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT
TROLAMINE9O3K93S3TKIACT
BENZETHONIUM CHLORIDEPH41D05744IACT
ALOE VERA LEAFZY81Z83H0XIACT
BOVINE TYPE I COLLAGENFHJ3ATL51CIACT

Source Document#

Source XML

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
59b669c4-f24a-4d5b-8026-31638935f599741d022f-954f-4686-b60e-08337235e9a72018-07-31WarningsExact identifier
spl id: 59b669c4-f24a-4d5b-8026-31638935f599
spl set id: 741d022f-954f-4686-b60e-08337235e9a7

Reported adverse events (FAERS/openFDA)#

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