{"active_ingredient":["Active ingredients Calamine 8% Pramoxine HCl 1%"],"adverse_reactions":["ADVERSE REACTION Like it or let us make it right. That's our quality promise. 855-423-2630 DISTRIBUTED BY UNFI PROVIDENCE, RI 02908 USA"],"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":"20260904","id":"5aa99c82-3d5d-b0a0-e063-6394a90a1b11","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 minor 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":["United Natural Foods, Inc. dba UNFI"],"package_ndc":["41163-536-30"],"product_ndc":["41163-536"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1234532"],"spl_id":["5aa99c82-3d5d-b0a0-e063-6394a90a1b11"],"spl_set_id":["0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea"],"substance_name":["FERRIC OXIDE RED","PRAMOXINE HYDROCHLORIDE"],"unii":["1K09F3G675","88AYB867L5"]},"package_label_principal_display_panel":["Principal display panel Compare to Caladryl ® Lotion active ingredients* NDC 41163-536-30 EQUALINE ® medicated calamine lotion external analgesic skin protectant drying action plus itch relief 6 FL OZ (177 mL) image description"],"purpose":["Purpose Skin protectant External analgesic"],"set_id":"0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea","spl_product_data_elements":["Calamine Calamine, Pramoxine HCl FERRIC OXIDE RED FERRIC OXIDE RED PRAMOXINE HYDROCHLORIDE PRAMOXINE ALCOHOL BENZYL ALCOHOL CAMPHOR (NATURAL) HYPROMELLOSE, UNSPECIFIED LAVENDER OIL PHENOXYETHANOL POLYSORBATE 80 PROPYLENE GLYCOL ROSEMARY OIL WATER XANTHAN GUM"],"spl_unclassified_section":["Other information store at room temperature (59°-77°F)","Disclaimer *This product is not manufactured or distributed by Bausch Health US, LLA, distributor of Caladryl Lotion Calamine Plus Itch Reliever."],"stop_use":["Stop use and ask a doctor condition worsens symptoms last more than 7 days or clear up and occur again within a few days"],"version":"8","warnings":["Warnings For external use only"],"when_using":["When using this product do not get into eyes"]}