Aurstat

Onset Dermatologics LLC

Aurstat Anti-Itch Hydrogel Kit

FULL PRESCRIBING INFORMATION: CONTENTS*

• SPL UNCLASSIFIED SECTION
• INDICATIONS FOR USE
• AURSTAT CONTRAINDICATIONS
• DIRECTIONS FOR USE
• INGREDIENTS
• WARNINGS
• PRECAUTIONS AND OBSERVATIONS
• INSTRUCTIONS FOR USE
• HOW SUPPLIED
• Aurstat Anti-Itche Hydrogel Kit Carton

FULL PRESCRIBING INFORMATION

SPL UNCLASSIFIED SECTION

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.

Under the supervision of a healthcare professional, HylatopicPlus^® Cream is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis.

HylatopicPlus^® Cream also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

AURSTAT CONTRAINDICATIONS

HylatopicPlus^® Cream is contraindicated in persons with a known hypersensitivity to any of the components of the formulation.

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.

Water, Glycerin, Ethylhexyl Palmitate, Cetearyl Alcohol, Propylene Glycol, Dicetyl Phosphate, Petrolatum, Theobroma Grandiflorum Seed Butter, Dimethicone, Ceteareth-10 Phosphate, Steareth-10, Phenoxyethanol, Hydroxypropyl Bispalmitamide MEA (Ceramide), Tocopheryl Acetate, Sodium Hyaluronate, Disodium EDTA and Sodium Hydroxide.

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.

Use only as directed.  Keep out of the reach of children. Avoid contact with eyes. For topical use only. Not for ophthalmic use. Do not apply within four hours prior to a radiation session.

PRECAUTIONS AND OBSERVATIONS

• HylatopicPlus® Cream does not contain a sunscreen and should not be used prior to extended exposure to the sun.
• If clinical signs of infection are present, appropriate treatment should be initiated; use of HylatopicPlus® Cream may be continued during the antiinfective therapy.

• If the condition does not improve within 10 – 14 days, consult a physician.

• HylatopicPlus® Cream may dissolve fuchsin when this dye is used to define the margins of the radiation fields to be treated.

INSTRUCTIONS FOR USE

Dispense HylatopicPlus^® Cream into palm of hand and apply to affected area 3 times per day, or as directed by a physician. Massage gently into the skin until completely absorbed. If the skin is broken, cover with appropriate dressing.

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

Caution: Federal law restricts this device to sale by or on the order of a physician or other licensed health care practitioner. Store between 59°F -86°F (15°C - 30°C).

Aurstat Anti-Itche Hydrogel Kit Carton

Aurstat Anti-Itch Hydrogel Kit Carton NDC 16781-445-96