{"active_ingredient":["Active Ingredient Pramoxine HCl (0.5%)"],"dosage_and_administration":["Directions Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: ask a doctor."],"effective_time":"20241105","id":"21faa84e-83c4-e381-e063-6294a90ae7e4","inactive_ingredient":["Inactive Ingredients Water, Glycerin, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Panthenol, Dimethicone, Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol, Cetyl Hydroxyethylcellulose, Chlorphenesin, Steareth-20, Aloe Barbadensis Leaf Extract, Sodium Chloride, Avena Sativa (Oat) Kernel Extract"],"indications_and_usage":["Use For the temporary relief of itching associated with: minor skin irritations"],"keep_out_of_reach_of_children":["Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M017"],"brand_name":["Aveeno Restorative Skin Therapy Itch Relief Balm"],"generic_name":["PRAMOXINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Kenvue Brands LLC"],"package_ndc":["69968-0637-4"],"product_ndc":["69968-0637"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1150482"],"spl_id":["21faa84e-83c4-e381-e063-6294a90ae7e4"],"spl_set_id":["61824ca7-a2d3-4830-b2bb-149a3222bfc8"],"substance_name":["PRAMOXINE HYDROCHLORIDE"],"unii":["88AYB867L5"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 113 g Tube Carton DERMATOLOGIST RECOMMENDED NEW Aveeno ® RESTORATIVE SKIN THERAPY SENSITIVE, DISTRESSED, DRY SKIN Itch Relief Balm Pramoxine HCL external analgesic prebiotic oat concentrate, aloe & pro-vit B5 instantly soothes & helps relieve itch net wt. 4 oz (113g) PRINCIPAL DISPLAY PANEL - 113 g Tube Carton"],"purpose":["Purpose External Analgesic"],"questions":["Questions? Call toll-free 866-428-3366 or 215-273-8755 (collect) or visit www.aveeno.com"],"set_id":"61824ca7-a2d3-4830-b2bb-149a3222bfc8","spl_product_data_elements":["Aveeno Restorative Skin Therapy Itch Relief Balm PRAMOXINE HYDROCHLORIDE GLYCERIN DISTEARYLDIMONIUM CHLORIDE PETROLATUM ISOPROPYL PALMITATE WATER CETYL ALCOHOL PANTHENOL DIMETHICONE OATMEAL BENZYL ALCOHOL CHLORPHENESIN STEARETH-20 ALOE VERA LEAF SODIUM CHLORIDE OAT PRAMOXINE HYDROCHLORIDE PRAMOXINE"],"spl_unclassified_section":["Drug Facts","Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558"],"stop_use":["Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days"],"storage_and_handling":["Other Information Store at Room Temperature"],"version":"5","warnings":["Warnings For external use only. When using this product Avoid contact with the eyes. Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product Avoid contact with the eyes."]}