Vexasyn

VEXASYN-
Sterling-Knight Pharmaceuticals, LLC

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
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NHRIC:69336-831
Inactive Ingredients
Ingredient Name Strength
WATER
LIDOCAINE HYDROCHLORIDE
SODIUM ALGINATE
GLYCERIN
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)
TROLAMINE
BENZETHONIUM CHLORIDE
ALOE VERA LEAF
BOVINE TYPE I COLLAGEN
Product Characteristics
(SPLSTERILEUSE) false
(SPLMRISAFE) true
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:69336-831-01 28.33 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
premarket notification K020540 01/01/2017
Labeler — Sterling-Knight Pharmaceuticals, LLC (079556942)
Establishment
Name Address ID/FEI Operations
Sterling-Knight Pharmaceuticals, LLC 079556942 label (69336-831), analysis (69336-831)

Revised: 07/2018 Sterling-Knight Pharmaceuticals, LLC

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