{"active_ingredient":["Active ingredient Capsaicin 0.025%"],"do_not_use":["Do not use • On wounds or damaged skin • If you are allergic to capsicum or chili peppers"],"dosage_and_administration":["Directions Adults and children 18 years of age and older: Apply a thin film of cream to affected area and gently rub in until fully absorbed unless treating hands. Wash hands thoroughly with soap and water immediately after application for best results. Apply 3 to 4 times daily. Children under 18 years : Ask a doctor"],"effective_time":"20241206","id":"1eb282ca-46c9-4da5-b2e8-40819f4a6677","inactive_ingredient":["Inactive ingredients Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, Methylsufonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, and Triethanolamine Capsaicin 0.025 % cream NDC 50488-1025-1 120 grams Capsaicin 0.025% cream NDC 50488-1025-5 50 grams Capsaicin 0.025% cream NDC 50488-1025-2 25 grams Alexso, Inc"],"indications_and_usage":["Uses Temporarily relieves minor aches and pains of muscles and joints due to: • simple backache • arthritis • strains • sprains"],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately."],"openfda":{"application_number":["M017"],"brand_name":["Capsaicin"],"generic_name":["CAPSAICIN"],"is_original_packager":[true],"manufacturer_name":["Alexso, Inc"],"package_ndc":["50488-1025-1","50488-1025-5","50488-1025-2"],"product_ndc":["50488-1025"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["198555"],"spl_id":["1eb282ca-46c9-4da5-b2e8-40819f4a6677"],"spl_set_id":["433da27d-04fb-481a-bbb0-874bb72c806a"],"substance_name":["CAPSAICIN"],"unii":["S07O44R1ZM"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 50488-1025-1 Capsaicin 0.025% Cream 120 grams PRINCIPAL DISPLAY PANEL NDC 50488-1025-1 Capsaicin 0.025% Cream 120 grams","PRINCIPAL DISPLAY PANEL NDC 50488-1025-5 Capsaicin 0.025% Cream 50 grams NDC 50488-1025-5 Capsaicin 0.025% Cream 50 grams","PRINCIPAL DISPLAY PANEL NDC 50488-1025-2 Capsaicin 0.025% Cream 25 grams NDC 50488-1025-2 Capsaicin 0.025% Cream 25 grams"],"purpose":["Purpose External analgesic"],"set_id":"433da27d-04fb-481a-bbb0-874bb72c806a","spl_product_data_elements":["Capsaicin Capsaicin CAPSAICIN CAPSAICIN WATER ARNICA MONTANA FLOWER INDIAN FRANKINCENSE CETOSTEARYL ALCOHOL CHONDROITIN SULFATE (BOVINE) ETHYLHEXYLGLYCERIN GLUCOSAMINE SULFATE GLYCERIN GLYCERYL MONOSTEARATE C13-14 ISOPARAFFIN ISOSTEARYL PALMITATE LAURETH-7 DIMETHYL SULFONE PEG-100 STEARATE PHENOXYETHANOL PROPYLENE GLYCOL STEARIC ACID"],"spl_unclassified_section":["CAPSAICIN – Capsaicin 0.025% Cream Alexso, Inc. Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- Capsaicin 0.025% Cream Drug Facts"],"stop_use":["Stop use and as k a doctor if • Condition worsens or does not improve after regular use • Severe burning persists or blistering occurs"],"storage_and_handling":["Other information Store at room temperature 15°-30°C (59°-86°F)"],"version":"6","warnings":["Warnings For external use only Read all warnings and directions before use. Test first on small area of skin. Do not use • On wounds or damaged skin • If you are allergic to capsicum or chili peppers Whe n us ing this product • You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days. • Avoid contact with the eyes, lips, nose and mucous membranes • Do not tightly wrap or bandage the treated area • Do not apply heat to the treated area immediately before or after use Stop use and as k a doctor if • Condition worsens or does not improve after regular use • Severe burning persists or blistering occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately."],"when_using":["Whe n us ing this product • You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days. • Avoid contact with the eyes, lips, nose and mucous membranes • Do not tightly wrap or bandage the treated area • Do not apply heat to the treated area immediately before or after use"]}