{"active_ingredient":["Active Ingredient Glycerin 20%"],"do_not_use":["DO NOT USE Do not use on Deep pumcture wounds or Animal Bites"],"dosage_and_administration":["Directions Apply liberally as often as necessary to cover affected areas. If gauze is used as a wound covering, moisten first. Children under 6 months: Consult a doctor before use"],"effective_time":"20240119","id":"0f4e25fa-bccd-b725-e063-6294a90ac340","inactive_ingredient":["Inactive Ingredients Allantoin, Aloe Vera gel, Diazolidinyl urea, Methylparaben, PEG-4 olivate, PEG-60, hydrogenated castor oil, Propylene glycol, Propylparaben, Purified water, Sodium Polyacrylate, Tetrasodium EDTA, Tocopherol acetate"],"indications_and_usage":["Uses Temporarily protects and helps relieve minor skin irritation and itching of minor cuts, scrapes and burns Maintains a moist wound environment Ideal for managment of stasis ulcers, pressure ulcers (stages 1-4), first and second degree burns, cuts, post-operative incisions, and skin conditions associated with peristomal care."],"keep_out_of_reach_of_children":["Keep out of the reach of children If swallowed get medical help or contact Poison Control Center right away"],"openfda":{"application_number":["M016"],"brand_name":["Hydro Gel"],"generic_name":["GLYCERIN 20%"],"is_original_packager":[true],"manufacturer_name":["Trifecta Pharmaceuticals USA LLC"],"nui":["N0000185370","N0000175629","N0000184306","N0000185001","M0000728","M0009417"],"package_ndc":["69396-127-03"],"pharm_class_cs":["Allergens [CS]","Glycerol [CS]"],"pharm_class_epc":["Non-Standardized Chemical Allergen [EPC]"],"pharm_class_pe":["Increased Histamine Release [PE]","Cell-mediated Immunity [PE]","Increased IgG Production [PE]"],"product_ndc":["69396-127"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"spl_id":["0f4e25fa-bccd-b725-e063-6294a90ac340"],"spl_set_id":["02e8e5d0-7844-39fe-e063-6394a90a57e1"],"substance_name":["GLYCERIN"],"unii":["PDC6A3C0OX"],"upc":["0850026393835"]},"package_label_principal_display_panel":["4852 GLOBE HYDROGEL 3OZ 062523 CDER"],"purpose":["Purpose Skin Protectant"],"questions":["Questions or Comments Call Toll Free 1-888-296-9067"],"set_id":"02e8e5d0-7844-39fe-e063-6394a90a57e1","spl_product_data_elements":["Hydro Gel Glycerin 20% ALOE VERA LEAF METHYLPARABEN PEG-4 OLEATE PROPYLENE GLYCOL .ALPHA.-TOCOPHEROL ACETATE ALLANTOIN WATER GLYCERIN GLYCERIN SODIUM POLYACRYLATE (2500000 MW) DIAZOLIDINYL UREA PROPYLPARABEN PEG-60 HYDROGENATED CASTOR OIL EDETATE SODIUM"],"spl_unclassified_section":["Drug Facts","Other information Store at room temperature 15°-30°C (59°-86°F) ** Tamper evident. Do not use if seal is damaged","Distributed By Distributed By Trifecta Pharmaceuticals USA® 101 NE Third Avenue Suite 1500 Fort Lauderdale, FL. 33301 USA www.trifecta-pharma.com"],"stop_use":["Stop use and ask a doctor condition worsens or does not improve within 10-14 days"],"version":"2","warnings":["Warning For External Use Only"],"when_using":["When Using this product Avoid contact with eyes"]}