{"active_ingredient":["Active ingredients Lidocaine 5% w/v Phenylephrine HCl 0.25% w/v"],"dosage_and_administration":["Directions • adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. • apply externally to the affected area up to 4 times daily. • children under 12 years of age: ask a doctor."],"effective_time":"20260611","id":"90fb3e2a-4b65-4bc1-99fc-4cc505e36a85","inactive_ingredient":["Inactive ingredients D&C Red No. 33, Disodium EDTA, Glycerin, Hydroxyethylcellulose, L-Cysteine HCl, Panthenol, Phenoxyethanol, Purified Water."],"indications_and_usage":["Uses • for the temporary relief of: • local itching and discomfort associated with hemorrhoids • burning • pain • soreness • temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders. • temporarily shrinks hemorrhoidal tissue."],"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":["M015"],"brand_name":["tina davies IceJelly Hemorrhoidal"],"generic_name":["LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["TINA DAVIES PROFESSIONAL LLC"],"nui":["N0000175682","M0000897","N0000175426","N0000175976"],"package_ndc":["84313-101-30","84313-101-15"],"pharm_class_cs":["Amides [CS]"],"pharm_class_epc":["Amide Local Anesthetic [EPC]","Antiarrhythmic [EPC]"],"pharm_class_pe":["Local Anesthesia [PE]"],"product_ndc":["84313-101"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1314136"],"spl_id":["90fb3e2a-4b65-4bc1-99fc-4cc505e36a85"],"spl_set_id":["580559bf-d91f-4bb3-9c9b-b7e2cd0686fd"],"substance_name":["LIDOCAINE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["98PI200987","04JA59TNSJ"],"upc":["0840058825275"]},"package_label_principal_display_panel":["Packaging tina davies IceJelly"],"purpose":["Purposes Local anesthetic Vasoconstrictor"],"questions":["Questions or comments? 1-888-510-1388 You may also report serious side effects to this phone number. Mon - Fri 9:00 AM - 5:00 PM"],"set_id":"580559bf-d91f-4bb3-9c9b-b7e2cd0686fd","spl_product_data_elements":["tina davies IceJelly Hemorrhoidal Lidocaine, Phenylephrine Hydrochloride LIDOCAINE LIDOCAINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE D&C RED NO. 33 EDETATE DISODIUM GLYCERIN HYDROXYETHYL CELLULOSE, UNSPECIFIED CYSTEINE HYDROCHLORIDE ANHYDROUS PANTHENOL PHENOXYETHANOL WATER"],"spl_unclassified_section":["Drug Facts","Maximum Strength Formula with local anesthetic and vasoconstrictor Manufactured for: Tina Davies Professional LLC 1020 Holland Drive, Unit 109 Boca Raton, FL 33487 Made in United Kingdom tinadavies.com"],"storage_and_handling":["Other information • store at 20–25°C (68–77°F). • protect from light. • do not use if seal is broken or missing."],"version":"1","warnings":["Warnings For external use only Allergy alert : certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor. Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are • presently taking a prescription drug for high blood pressure or depression. When using this product • do not exceed the recommended daily dosage unless directed by a doctor. • do not put this product into the rectum by using fingers or any mechanical device or applicator. • in case of bleeding, consult a doctor promptly. Stop use and ask a doctor if • condition worsens or does not improve within 7 days. • an allergic reaction develops. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."]}