AURSTAT- dressing, wound, drug
Onset Dermatologics LLC
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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.
Rx Only
For Topical Dermatological and External Use Only
Symptom relief for atopic dermatitis, allergic contact dermatitis, and radiation dermatitis.
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.
HylatopicPlus® Cream is contraindicated in persons with a known hypersensitivity to any of the components of the formulation.
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.
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.
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.
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.
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.
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
HylatopicPlus® Cream is available in 3g professional sample tubes (NDC 16781-216-04), 100g commercial tubes (NDC 16781-216-96) and 450g commercial jars (16781-216-16).
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).
Manufactured for:
Onset Dermatologics
Cumberland, RI 02864
(888) 713-8154
www.onsetdermatologics.com
AURSTAT
dressing, wound, drug kit |
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Labeler - Onset Dermatologics LLC (793223707) |