VEXASYN- dressing, wound and burn, hydrogel w/drug and/or biologic    
Sterling-Knight Pharmaceuticals, LLC

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Vexasyn Gel
Prescription Only | Rx Only

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

Directions:

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

Indications:

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

Warnings:

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:

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

Storage:

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

Ingredients:

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

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

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

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


Rev 121517-1

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VEXASYN 
dressing, wound and burn, hydrogel w/drug and/or biologic
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NHRIC:69336-831
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
TROLAMINE (UNII: 9O3K93S3TK)  
BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BOVINE TYPE I COLLAGEN (UNII: FHJ3ATL51C)  
Product Characteristics
(SPLSTERILEUSE)false
(SPLMRISAFE)true
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:69336-831-0128.33 g in 1 BOTTLE; Type 0: Not a Combination Product01/02/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
premarket notificationK02054001/01/2017
Labeler - Sterling-Knight Pharmaceuticals, LLC (079556942)
Establishment
NameAddressID/FEIBusiness Operations
Sterling-Knight Pharmaceuticals, LLC079556942label(69336-831) , analysis(69336-831)

Revised: 7/2018
Document Id: 59b669c4-f24a-4d5b-8026-31638935f599
Set id: 741d022f-954f-4686-b60e-08337235e9a7
Version: 3
Effective Time: 20180731
 
Sterling-Knight Pharmaceuticals, LLC