{"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. Vitamin E has been used as an aid to control dry or chapped skin, and for the relief of and discomfort from minor skin disorders such as burns, sunburn and irritated skin. It has antioxidant properties thus protecting the skin. INGREDIENTS: Active: Lactic Acid 10%. Inactives: Water, Vitamin E 3500 IU/oz., Glyceryl Stearate (and) PEG-100 Stearate, Cetyl Alcohol, Glycerine, PEG-40 Stearate, Caprylic Capric Triglyceride, Lecithin, Dimethicone, EDTA, Methylparaben, Propylparaben, Diazolidinyl Urea, Sodium Benzoate."],"dosage_and_administration":["DIRECTIONS Apply thoroughly twice a day onto the affected areas or as directed by your PODIATRIST, DERMATOLOGIST or PHYSICIAN."],"effective_time":"20091119","how_supplied":["HOW SUPPLIED Available in a 4 oz. (113.4g) plastic jar and an 8 oz. (226.8g) tube. Store at controlled room temperature 15° - 30°C (59° - 86°F)."],"id":"8340abfa-0a5b-4258-985a-9c00b2dfbd06","indications_and_usage":["INDICATIONS Lactinol-E Creme is indicated for moisturizing, softening of dry, scaly skin (Xerosis), ichthyosis vulgaris and for the temporary relief of itching associated with these conditions. APPROVED BY THE AMERICAN PODIATRIC MEDICAL ASSOCIATION."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - Jar Label NDC 0884-4990-04 LACTINOL-E ® CREME RELIEF OF DRY, SCALY ITCHING SKIN FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC USE Rx Only PEDiNOL PHARMACAL INC. NET WT. 4 OZ. (113.4g) PRINCIPAL DISPLAY PANEL - Jar Label"],"precautions":["PRECAUTIONS FOR EXTERNAL USE ONLY. PATIENTS SHOULD BE ADVISED TO KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. Avoid contact with eyes, lips and mucous membranes. Not for use in patients known to be sensitive to any of the 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. Lactinol-E Creme should be given to a pregnant woman only if clearly needed, and caution should be exercised when Lactinol-E Creme is administered to a nursing mother. Safety and effectiveness in pediatric patients have not been established."],"set_id":"d1592900-9164-489f-899a-58721eabbc7d","spl_product_data_elements":["Lactinol-E Lactic Acid Lactic Acid Lactic Acid water Alpha-Tocopherol Acetate Glyceryl Monostearate Polyoxyl 100 Stearate Cetyl Alcohol Glycerin Polyoxyl 40 Stearate Lecithin, Soybean Dimethicone Edetic Acid Methylparaben Propylparaben Diazolidinylurea Sodium Benzoate"],"spl_unclassified_section":["NDC 0884-4990-04 NDC 0884-4990-08 RELIEF OF DRY, SCALY ITCHING SKIN FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE.","Rx ONLY. Manufactured for: PEDINOL PHARMACAL INC. 30 Banfi Plaza No. Farmingdale, NY 11735 REV 504"],"storage_and_handling":["Store at controlled room temperature 15° - 30°C (59° - 86°F)."],"version":"1","warnings":["WARNING Sun exposure (natural or artificial sunlight) to areas of the skin treated with Lactinol-E Creme should be minimized or avoided."]}