{"active_ingredient":["Active Ingredient Lidocaine HCI 4%"],"do_not_use":["Do Not Use On large areas of the body or on cut, irritated or swollen skin On puncture wounds For more than one week without consulting a doctor"],"dosage_and_administration":["Directions Adults and children over 12 years: Apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period. Children 12 years or younger: ask a doctor"],"effective_time":"20241220","id":"29b3acd1-d36c-c0b4-e063-6394a90a5234","inactive_ingredient":["Inactive Ingredient: Cetostearyl alcohol, Ethylparaben, Glycerin, Glyceryl Sterate, Light Mineral Oil, Petrolatum, Polyoxyethylene Lauryl Ether, Purified Water, Sodium Lauryl Sulfate."],"indications_and_usage":["Uses Temporarily relieves minor 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":["M017"],"brand_name":["Pain Itch Relief"],"generic_name":["LIDOCAINE HCI"],"is_original_packager":[true],"manufacturer_name":["Trifecta Pharmaceutical USA LLC"],"package_ndc":["69396-120-17"],"product_ndc":["69396-120"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1010895"],"spl_id":["29b3acd1-d36c-c0b4-e063-6394a90a5234"],"spl_set_id":["f40b19a8-795c-f514-e053-2a95a90a6d15"],"substance_name":["LIDOCAINE HYDROCHLORIDE"],"unii":["V13007Z41A"],"upc":["0850026393668"]},"package_label_principal_display_panel":["Packaging Globe Lidocaine Cream 49.6g CDER"],"pregnancy_or_breast_feeding":["If Pregnant or Breast Feeding Ask a health professional before use."],"purpose":["Purpose Topical Anesthetic"],"questions":["Questions For Questions please call 1 888 296 9067"],"set_id":"f40b19a8-795c-f514-e053-2a95a90a6d15","spl_product_data_elements":["Pain Itch Relief Lidocaine HCI STEARETH-21 PHENOXYETHANOL WATER CYCLOMETHICONE 7 EDETATE DISODIUM ANHYDROUS GLYCERYL MONOSTEARATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) MALTODEXTRIN ISOHEXADECANE AMINOMETHYLPROPANOL CETOSTEARYL ALCOHOL CETETH-10 PHOSPHATE DIHEXADECYL PHOSPHATE DIMETHICONE ETHYLHEXYLGLYCERIN HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) ALCOHOL ALOE VERA LEAF LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS CARBOMER INTERPOLYMER TYPE A (55000 CPS)"],"spl_unclassified_section":["DRUG FACTS","Distributed By T rifecta Pharmaceuticals USA 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL. 33301 USA www.trifecta-pharma.com This product is not manufactured or distributed by Chattem, Inc. a Sanofi Company owner of the registered trademark Gold Bond."],"stop_use":["Stop Use and ask a Doctor if: Condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days."],"storage_and_handling":["Other Information Store at room temperature"],"version":"2","warnings":["Warnings For external use only."],"when_using":["When using this product Use only as directed. Do not allow contact with eyes. Do not bandage or apply local heat such as heating pads to the area of use"]}