{"active_ingredient":["Active Ingredient Phenylephrine HCI 0.25%","Active Ingredient Witch Hazel 50%"],"dosage_and_administration":["Directions Children under 12 years of age; ask a doctor before use Adults: when practical, clean the affected area by patting or blotting with an appropriate cleansing wipe gently dry by patting or blotting with a tissue or soft cloth before applying when first opening tube, remove foil seal apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement"],"effective_time":"20241218","id":"298d9e2d-7fff-7f15-e063-6394a90a1639","inactive_ingredient":["Inactive Ingredients Aloe barbadensis gel, benzophenone-4, Acetate disodium, Hydroxyethylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, sodium citrate, Vitamin E, water"],"indications_and_usage":["Uses Helps relieve the local itching and discomfort associated with hemorrhoids temporarily relief of irritation and burning temporarily shrinks hemorrhoidal tissue aids in protecting irritated anorectal areas"],"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":["M015"],"brand_name":["Hemorroidal Cooling gel"],"generic_name":["PHENYLEPHRINE, WITCH HAZEL"],"is_original_packager":[true],"manufacturer_name":["Trifecta Pharmaceuticals Usa Llc"],"package_ndc":["69396-032-18"],"product_ndc":["69396-032"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"spl_id":["298d9e2d-7fff-7f15-e063-6394a90a1639"],"spl_set_id":["651c0143-384c-3649-e053-2991aa0a0f28"],"substance_name":["WITCH HAZEL","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["101I4J0U34","04JA59TNSJ"],"upc":["0040232622717"]},"package_label_principal_display_panel":["Packaging globe_cooling_gel"],"pregnancy_or_breast_feeding":["If pregnant or breast feeding Ask a doctor before use"],"purpose":["Purpose Vasoconstrictor","Purpose Astringent"],"questions":["Questions or Comments Call Toll Free 1-888-296-9067"],"set_id":"651c0143-384c-3649-e053-2991aa0a0f28","spl_product_data_elements":["Hemorroidal Cooling gel Phenylephrine, Witch Hazel WITCH HAZEL WITCH HAZEL POLYSORBATE 80 METHYLPARABEN SULISOBENZONE EDETATE DISODIUM EDETIC ACID PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ALOE VERA LEAF WATER SODIUM CITRATE PROPYLENE GLYCOL .ALPHA.-TOCOPHEROL ACETATE, D- PROPYLPARABEN HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)"],"spl_unclassified_section":["Drug Facts","Other information Store at room temperature 20°-25°C (68°-77°F) Do not use if tube seal under cap is broken or missing ** This product is not manufactured or distributed by Wyeth Consumer Healthcare Inc. owner of the registered trademark Preparation H®","Distributed By Trifecta Pharmaceuticals USA™ 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL. 33301, USA 1-888-296-9067"],"stop_use":["Stop use and ask a doctor bleeding occurs condition worsens or does not improve within 7 days introduction of applicator into the rectum causes additional pain"],"version":"6","warnings":["Warnings For External Use Only Ask doctor before use if you have heart disease high blood pressure thyroid disease diabetes difficulty urinating due to an enlarged prostate gland Ask doctor 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 into the rectum by using fingers or any mechanical device or applicator"]}