{"active_ingredient":["Active ingredients Lidocaine HCl 5% Phenylephrine HCl 0.25%"],"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: consult a doctor."],"effective_time":"20260709","id":"5282563a-c4f4-48d2-90ca-aac5fa7318ec","inactive_ingredient":["Inactive ingredients Acetyl Hexapeptide-8, Butylene Glycol, Carboxymethyl Cellulose 2500, Chloroxylenol, Hexanediol CG, Pentapeptide-18, Phenoxyethanol, Ethylhexylglycerin, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Propylene Glycol, Sodium Hyaluronate, Water (Aqua)."],"indications_and_usage":["Uses • For the temporary relief of anorectal itching and discomfort associated with hemorrhoids. • For temporary relief of pain."],"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 IceCream"],"generic_name":["LIDOCAINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["TINA DAVIES PROFESSIONAL LLC"],"package_ndc":["84313-001-30","84313-001-05","84313-001-15"],"product_ndc":["84313-001"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["2684985"],"spl_id":["5282563a-c4f4-48d2-90ca-aac5fa7318ec"],"spl_set_id":["6a2b3199-f405-4455-9a02-8885d24eef9c"],"substance_name":["LIDOCAINE HYDROCHLORIDE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["V13007Z41A","04JA59TNSJ"],"upc":["0846667003011"]},"package_label_principal_display_panel":["Packaging IceCream IceCream"],"purpose":["Purpose Local anesthetic Vasoconstrictor"],"set_id":"6a2b3199-f405-4455-9a02-8885d24eef9c","spl_product_data_elements":["Tina Davies IceCream Lidocaine Hydrochloride, Phenylephrine Hydrochloride LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACETYL HEXAPEPTIDE-8 AMIDE BUTYLENE GLYCOL CARBOXYMETHYLCELLULOSE CALCIUM CHLOROXYLENOL HEXANEDIOL PENTAPEPTIDE-18 PHENOXYETHANOL ETHYLHEXYLGLYCERIN POLYACRYLAMIDE (10000 MW) C12-14 ISOPARAFFIN LAURETH-7 PROPYLENE GLYCOL HYALURONATE SODIUM WATER"],"spl_unclassified_section":["Drug Facts","2-in-1 Maximum Strength Formula Hemorrhoidal cream with vasoconstrictor and local anesthetic Manufactured for Tina Davies Professional LLC 1020 Holland Drive, Unit 109 Boca Raton, FL 33487 1-888-510-1388 tinadavies.com"],"version":"7","warnings":["Warnings For external use only Allergy alert: Certain persons can develop allergic reactions to ingredients in this product. 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, or 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. Stop use and ask a doctor if • Condition worsens or does not improve within 7 days. • Bleeding occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."]}