Aurstat

Onset Dermatologics LLC

Aurstat Anti-Itch Hydrogel

FULL PRESCRIBING INFORMATION: CONTENTS*

• INDICATIONS FOR USE
• DIRECTIONS FOR USE
• INGREDIENTS
• WARNINGS
• HOW SUPPLIED
• PACKAGE LABEL PRINCIPLE DISPLAY PANEL

FULL PRESCRIBING INFORMATION

Rx Only – Prescription Medical Device

Caution: Federal Law restricts this device to sale by or on the order of a licensed healthcare practitioner in the state that this product is prescribed.

INDICATIONS FOR USE

Aurstat^® Anti-Itch Hydrogel is indicated for the management and relief of pain, burning and itching experienced with various dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis, as well as for the relief of pain from first and second degree burns, and aids to relieve dry waxy skin by maintaining a moist wound and skin environment. A moist wound and skin environment is beneficial to the healing process.

DIRECTIONS FOR USE

Shake well before each use. Cleanse the area and blot dry. Apply a thin layer of Aurstat to the affected and immediately surrounding area. Use once or twice daily or as directed by a physician. Cover the area with bandage as necessary.

INGREDIENTS

Sodium Magnesium Fluorosilicate, Cyclomethicone, Phosphoric Acid, Sodium Chloride, Sodium Bicarbonate, Hypochlorous Acid, Water.

The hydrogel contains (0.045%) hypochlorous acid as a preservative to inhibit growth of microorganisms within the product. The hydrogel has been shown to be active against a range of microorganisms in in-vitro preservative tests. The effect of this product in the wound bed has not been clinically tested.

WARNINGS

Aurstat should not be used to treat any condition other than that for which it is prescribed.

KEEP OUT OF REACH OF CHILDREN. For external use only. Avoid contact with the eyes.

Store with cap closed tightly after each use in its original container. Store at controlled room temperature 59-77˚F (15-25˚C). Keep away from direct sunlight and heat sources. Do not freeze.

HOW SUPPLIED

Aurstat Anti-Itch Hydrogel is supplied in a 225mL trade size bottle and a 50mL professional sample bottle.

Patent Protected

Manufactured for:

Onset Dermatologics

Cumberland, RI 02864

1-888-713-8154

www.onsetdermatologics.com

Manufactured by:

PuriCore Inc.

508 Lapp Road

Malvern, PA 19355

P/N 2657 Rev. 0

PACKAGE LABEL PRINCIPLE DISPLAY PANEL

Package Label-Principal Display Panel - 225mL Carton

Aurstat Anti-Itch Hydrogel Carton  NDC 16781-349-96