{"contraindications":["CONTRAINDICATION Not for use in patients know to be sensitive to the active or inactive ingredients in Lactic Acid 10% Lotion."],"description":["DESCRIPTION Lactic Acid, an alpha-hydroxy acid, is a natural skin-moisturizing agent. It has beneficial effects on dry skin (xerosis) and in severe discomfort of hyperkeratotic conditions. INGREDENTS Active Ingredient: Lactic Acid 10%, Inactive Ingredients: Purified Water, Isopropyl Palmitate, Cetyl Alcohol, Gylceryl Stearate and PEG 100 Stearate, PEG-40 Stearate, Caprylic/Caprylic Triglyceride, Lecithin, Dimethicone, Glycerin, Methylparaben, Propylparben, Disodium EDTA, Imidurea and Sodium Benzoate."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Apply thoroughly twice daily on affected areas or as prescribed by a Physician. Dispense in accordance with applicable state law. This product has not been approved by the FDA, is not listed in the Orange Book, and has not been approved or rated for therapeutic equivalence with any other product."],"effective_time":"20171130","how_supplied":["HOW SUPPLIED 12 oz. (354.84ml) net wt. high density polyethylene bottle NDC 58980-918-95 STORAGE Store at controlled room temperature 15° - 30°C (59° - 86°F). See bottom of bottle for lot number and expiration date."],"id":"0c1faba7-4c92-4141-9302-9821c2265355","indications_and_usage":["INDICATIONS AND USAGE Lactic Acid 10% Lotion is a white rich moisturizer for dry skin (xerosis) and is indicated to moisturize and soften dry, itchy skin and minor skin irritation."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 354.84 mL Label NDC 58980-918-95 Rx only LACTIC ACID 10% LOTION For dry, itchy skin and minor skin irritation For Topical Use Only STRATUS PHARMACEUTICALS INC Net WT. 12.0 fl. oz. (354.84 mL) Principal Display Panel - 354.84 mL Label"],"precautions":["PRECAUTIONS FOR EXTERNAL USE ONLY. KEEP OUT OF THE REACH OF CHILDREN. Do not use in or near eyes, lips or mucous membranes. Patient may experience mild stinging or burning and peeling may occur on sensitive or irritated skin areas. If sensitivity or irritation occurs, immediately discontinue use and consult a medical professional. Caution is advised when used on the face due to the potential for irritation. The potential for post-inflammatory hypo-hyperpigmentation has not been studied. Avoid administering Lactic Acid 10% Lotion to pregnant women unless clearly required and use caution in its use for nursing mothers. Safety and effectiveness in pediatric patients have not been established."],"set_id":"7284e57d-a0bd-43ba-994d-dcdbac3fd368","spl_product_data_elements":["Lactic Acid Lactic Acid LACTIC ACID, UNSPECIFIED FORM LACTIC ACID, UNSPECIFIED FORM"],"spl_unclassified_section":["For dry itchy skin and minor skin irritation FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only","Distributed by STRATUS PHARMACEUTICALS INC Manufactured for Stratus Pharmaceuticals Inc. 12379 Southwest 130th Street Miami, Florida 33186-6727 Customer Service Telephone: 1-800-442-7882 Fax: 305-254-6875 JG LAL02008-1210"],"storage_and_handling":["STORAGE Store at controlled room temperature 15° - 30°C (59° - 86°F). See bottom of bottle for lot number and expiration date."],"version":"2","warnings":["WARNINGS Minimize or avoid sun exposure to areas of the skin treated with Lactic Acid 10% Lotion."]}