{"active_ingredient":["Active ingredients Calamine 8% Pramoxine HCl 1%"],"adverse_reactions":["ADVERSE REACTION DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007 ©TOPCO VIJA0622 QUESTIONS? 1-888-423-0139 topcare@topco.com www.topcarebrand.com Quality Guaranteed Visit here for more information: http://topbrnds.com/4901jm"],"dosage_and_administration":["Directions shake well before applying was affected are of skin 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 - do not use, ask a doctor"],"effective_time":"20260213","id":"4ab90806-7257-8b97-e063-6294a90a71c3","inactive_ingredient":["Inactive ingredients alcohol, benzyl alcohol, camphor, fragrance, hydroxypropyl methylcellulose, Lavandula angustifolia (lavender) oil, phenoxyethanol, polysorbate 80, propylene glycol, Rosmarinus officinalis (rosemary) leaf oil, water, xanthan gum"],"indications_and_usage":["Use for the temporary relief of pain and itching associated with minot skin irritations and rashes due to poison ivy, poison oak, or poison sumac dries the oozing and weeping of poison: ivy oak sumac"],"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":["M016"],"brand_name":["Calamine"],"generic_name":["CALAMINE, PRAMOXINE HCL"],"is_original_packager":[true],"manufacturer_name":["Topco Associates LLC"],"package_ndc":["76162-336-30"],"product_ndc":["76162-336"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1234532"],"spl_id":["4ab90806-7257-8b97-e063-6294a90a71c3"],"spl_set_id":["15d1ae3f-509c-4e6b-8f0c-cf9265680358"],"substance_name":["FERRIC OXIDE RED","PRAMOXINE HYDROCHLORIDE"],"unii":["1K09F3G675","88AYB867L5"]},"package_label_principal_display_panel":["principal display panel TopCare ® Health COMPARE TO CALADRYL ® LOTION ACTIVE INGREDIENTS* NDC 76162-336-30 MEDICATED Calamine Lotion EXTERANAL ANALGESIC/SKIN PROTECTANT For Relief from Pain & Itching Due to: Poison Ivy, Oak & Sumac Insect Bites Minor Skin Irritations 6 FL OZ (177 mL) image description"],"purpose":["Purpose Skin protectant External analgesic"],"set_id":"15d1ae3f-509c-4e6b-8f0c-cf9265680358","spl_product_data_elements":["Calamine Calamine, Pramoxine HCl BENZYL ALCOHOL ALCOHOL CAMPHOR (NATURAL) HYPROMELLOSE, UNSPECIFIED LAVENDER OIL PHENOXYETHANOL POLYSORBATE 80 PROPYLENE GLYCOL ROSEMARY OIL WATER XANTHAN GUM FERRIC OXIDE RED FERRIC OXIDE RED PRAMOXINE HYDROCHLORIDE PRAMOXINE"],"spl_unclassified_section":["Other information store at room temperature (59°-77°F)","Disclaimer *This product is not manufactured or distributed by Bausch Health US, LLC, distributer of Caladryl Lotion Calamine Plus Itch Reliever"],"stop_use":["Stop use and ask a doctor condition worsens symptoms last more than 7 days or clean up and occur again within a few days"],"version":"7","warnings":["Warnings For external use only"],"when_using":["When using this product do not get into eyes"]}