{"contraindications":["Contraindications: Not for use in patients known to be sensitive to any of the ingredients in Lactic Acid Lotion."],"description":["Description: Lactic Acid has been reported as an effective naturally occurring humectant in the skin. It has beneficial effects on dry skin and in severe discomfort of hyperkeratotic conditions."],"dosage_and_administration":["Directions: Apply thoroughly twice a day onto the affected areas or as directed by your PODIATRIST, DERMATOLOGIST or 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":"20091210","how_supplied":["River's Edge Lactic Acid Lotion is available in a 12 oz. (354.84mL) plastic bottle, NDC 68032-125-12 or a 16 oz. (473.12mL) plastic bottle, NDC 68032-125-16. Store at controlled room temperature 15º - 30ºC (59º - 86ºF). Rx Only. Rev. 10/06 Logo"],"id":"d0330c18-e160-4e32-a148-b24c1e48fcf6","inactive_ingredient":["Inactives: Isopropyl Palmitate, Cetyl Alcohol, Glyceryl Stearate and PEG 100 Stearate, PEG 40 Stearate, Caprylic / Capric Triglyceride, Lecithin, Dimethicone, Glycerine, Methyl Paraben, Propyl Paraben, Disodium EDTA, Purified Water, Imidurea and Sodium Benzoate."],"indications_and_usage":["Indications: For moisturizing and softening dry, scaly skin (xerosis), ichthyosis vulgaris and for the temporary relief of itching associated with these conditions."],"openfda":{},"package_label_principal_display_panel":["Drug Facts ACTIVE INGREDIENT Purpose Lactic Acid 10% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Moisturizer for dry skin (xerosis) USES • treats dry, scaly skin (xerosis) • moisturizes and softens dry, scaly skin • temporary relief of itching associated with these conditions WARNINGS • for external use only • avoid sun exposure to area treated PRECAUTIONS • do not use in or near eyes, lips and mucous membranes • stop use and ask PODIATRIST, DERMATOLOGIST or PHYSICIAN if irritation or sensitivity occurs • do not use on face due to potential irritation Keep out of reach of children DIRECTIONS • apply thoroughly twice a day onto affected areas OTHER INFORMATIO N • store at controlled room temperature 15º-30ºC (59º-86ºF) • see package insert for additional information • 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. INACTIVE INGREDIENTS Isopropyl Palmitate, Cetyl Alcohol, Glyceryl Stearate and PEG 100 Stearate, PEG 40 Stearate, Caprylic / Capric Triglyceride, Lecithin, Dimethicone, Glycerine, Methyl Paraben, Propyl Paraben, Disodium EDTA, Purified Water, Imidurea and Sodium Benzoate. Manufactured for: River's Edge Pharmaceuticals, LLC. Suwanee, GA 30024 REV. 06/06 Barcode Label"],"precautions":["Precautions: FOR EXTERNAL USE ONLY. PATIENT SHOULD BE ADVISED TO KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. Avoid contact with eyes, lips or mucous membranes. Not for use in patients known to be sensitive to any ingredients in this product. A mild, stinging, burning or peeling may occur on sensitive, inflamed or irritated skin areas. If irritation or sensitivity occurs, patient should discontinue use and notify their PODIATRIST, DERMATOLOGIST or PHYSICIAN for appropriate therapy. Caution is advised when used on the face due to the potential for irritation. The potential for post-inflammatory hypo- or hyperpigmentation has not been studied. Lactic Acid Lotion should be given to a pregnant woman only if clearly needed, and caution should be exercised when Lactic Acid Lotion is administered to a nursing mother. Safety and effectiveness in pediatric patients have not been established."],"set_id":"56d1d230-29c9-431d-9f0e-3902f9e17564","spl_product_data_elements":["LACTIC ACID LACTIC ACID Lactic Acid Lactic Acid"],"version":"6","warnings":["Warnings: Sun exposure (natural or artificial sunlight) to area of skin treated with Lactic Acid Lotion should be minimized or avoided."]}