{"active_ingredient":["Active ingredient Pramoxine Hydrochloride 1%"],"dosage_and_administration":["Directions to open, hold cap tightly and turn pump counter-clockwise 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: consult a doctor"],"effective_time":"20241107","id":"119ef16e-c873-41df-9e98-4ccade286a85","inactive_ingredient":["Inactive ingredients Benzyl Alcohol, Carbomer 940, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Isopropyl Myristate, Petrolatum, PEG-8 Stearate, PEG-100 Stearate, Purified Water, Sodium Hydroxide, Stearic Acid."],"indications_and_usage":["Uses for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations and rashes due to poison ivy, poison oak, or poison sumac"],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately"],"openfda":{"application_number":["M017"],"brand_name":["Peviderm Pramoxine Hydrocholride 1%"],"generic_name":["PRAMOXINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Stratus Pharmaceuticals Inc"],"package_ndc":["58980-913-80"],"product_ndc":["58980-913"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"spl_id":["119ef16e-c873-41df-9e98-4ccade286a85"],"spl_set_id":["680b40fa-1922-443a-a4b0-7c3f6a2b847d"],"substance_name":["PRAMOXINE HYDROCHLORIDE"],"unii":["88AYB867L5"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 222 mL Bottle Box NDC 58980-913-80 Steroid-Free & Fragrance-Free PEVIDERM™ PRAMOXINE HYDROCHLORIDE 1% ITCH RELIEF FOR SENSITIVE SKIN EXTERNAL ANALGESIC LOTION Moisturizes and gently relieves itch associated with: Eczema and Dry Sensitive Skin Net 7.5 fl oz (222 mL) PRINCIPAL DISPLAY PANEL - 222 mL Bottle Box"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use"],"purpose":["Purpose External Analgesic"],"questions":["Questions or comments? Call us at 1-800-442-7882"],"set_id":"680b40fa-1922-443a-a4b0-7c3f6a2b847d","spl_product_data_elements":["Peviderm Pramoxine Hydrocholride 1% Pramoxine Hydrochloride Pramoxine Hydrochloride PRAMOXINE Water Glyceryl Stearate/PEG-100 Stearate PEG-8 Stearate Calcium Chloride CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) Cetyl Palmitate Isopropyl Myristate White Petrolatum Stearic Acid Benzyl Alcohol Sodium Hydroxide"],"spl_unclassified_section":["Drug Facts","Distributed by: STRATUS PHARMACEUTICALS INC Miami, Florida 33186"],"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 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]"],"version":"2","warnings":["Warnings for external use only When using this product avoid contact with 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 If pregnant or breast-feeding, ask a health professional before use Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately"],"when_using":["When using this product avoid contact with eyes"]}