{"adverse_reactions":["ADVERSE REACTIONS","ADVERSE REACTIONS If any adverse reaction occurs, discontinue use and seek the attention of a physician."],"contraindications":["CONTRAINDICATIONS This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product."],"description":["DESCRIPTION Each mL contains 1 mg of sodium hyaluronate, carbomer 980, imidazolidinyl urea, methylparaben, propylparaben, purified water, and triethanolamine."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Apply to the affected area(s) and rub in thoroughly. Use a liberal amount two to three times daily or as directed by a physician."],"effective_time":"20200330","how_supplied":["HOW SUPPLIED This product is supplied in the following size(s): 12 fl. oz. (340 mL) bottles, NDC 57893-314-12 To report a serious adverse event or obtain product information, call 1-855-899-4237. Manufactured for: Artesa Labs, LLC 13785 Research Blvd. Suite 125 Austin, TX 78750 1900293 [00] Rev. 01/2020"],"id":"a2157f27-e59d-400b-e053-2995a90a83e5","indications_and_usage":["INDICATIONS This product is indicated in the treatment of symptoms associated with xerosis (dry, scaly skin)."],"openfda":{},"package_label_principal_display_panel":["label.jpg"],"precautions":["PRECAUTIONS FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. General: This product is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use and consult a physician. Information for Patients: Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. Avoid contact with eyes, lips and mucous membranes. Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies for carcinogenic potential have not been performed on this product to date. Studies on reproduction and fertility also have not been performed. Pregnancy: Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman."],"set_id":"9c0af50f-0f2f-cc8c-e053-2995a90ab2f6","spl_product_data_elements":["Hylinate HYALURONATE SODIUM HYALURONATE SODIUM HYALURONIC ACID"],"spl_unclassified_section":["Rx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE."],"storage_and_handling":["STORAGE Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. NOTICE: Protect from freezing and excessive heat. Keep container tightly closed."],"version":"2","warnings":["WARNINGS KEEP OUT OF REACH OF CHILDREN."]}