{"active_ingredient":["Active Ingredients Histamine Dihydrochloride .025%"],"dosage_and_administration":["Dosage and Administration Apply a thin layer to pain site and massage until thoroughly absorbed into skin. Apply no more than 3 to 4 times daily."],"effective_time":"20260521","id":"5256a63e-e6db-84c1-e063-6294a90a8dff","inactive_ingredient":["Inactive Ingredients Aloe Barbadensis Leaf (Aloe Vera Gel), Aqua (Purified Water), Ascorbic Acid (Vitamin C), Arnica Montana Flower Extract, Boswellia Serrata Extract, Bromelain, Butylene Glycol, Chamomilla Recutita (Chamomile) Extract, Emu Oil, Ethylhexylglycerin, Ethylhexyl Stearate, Ganoderma Lucidum (Reishi Mushroom) Extract, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Seed Oil, C13-14 Isoparaffin, Laureth-7, Magnesium Sulfate, Methylsulfonylmethane (MSM), Niacin, Phenoxyethanol, Polyacrylamide, Potassium Sorbate, Sodium Polyacrylate, Tetrasodium EDTA, Tochopheryl Acetate (Vitamin E), Trideceth-6, Turmeric Extract, Zingiber Officinalis (Ginger) Extract"],"indications_and_usage":["Indications & Usage Section For temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains and bruises. When using this product: avoid contact with eyes. If product gets into eyes, rinse thoroughly with water. Do not bandage tightly or use a heating pad."],"keep_out_of_reach_of_children":["Keep out of reach of children Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away"],"openfda":{"application_number":["M017"],"brand_name":["Australian Dream Back Pain"],"generic_name":["HISTAMINE DIHYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Sombra Cosmetics Inc."],"package_ndc":["61577-8121-2","61577-8121-3","61577-8121-4","61577-8121-5","61577-8121-9","61577-8121-8"],"product_ndc":["61577-8121"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1542820"],"spl_id":["5256a63e-e6db-84c1-e063-6294a90a8dff"],"spl_set_id":["5256a63e-e6da-84c1-e063-6294a90a8dff"],"substance_name":["HISTAMINE DIHYDROCHLORIDE"],"unii":["3POA0Q644U"],"upc":["0694603827142"]},"package_label_principal_display_panel":["AD 2 oz Back Pain Cream Box AD 2 oz Back Pain Cream Box"],"purpose":["Purpose Topical Analgesic"],"questions":["Questions or Comments Call 1-888-600-4642"],"recent_major_changes":["Indications and Usage Section January 2024: For temporary relief of minor aches and pains of muscles and joints associated with simple backache March 2026: For temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains and bruises. When using this product: avoid contact with eyes. If product gets into eyes, rinse thoroughly with water. Do not bandage tightly or use a heating pad."],"set_id":"5256a63e-e6da-84c1-e063-6294a90a8dff","spl_product_data_elements":["Australian Dream Back Pain Histamine Dihydrochloride WATER ETHYLHEXYLGLYCERIN PHENOXYETHANOL BUTYLENE GLYCOL POTASSIUM SORBATE GANODERMA LUCIDUM WHOLE TETRASODIUM EDTA ETHYLHEXYL STEARATE TRIDECETH-6 GINGER EMU OIL HISTAMINE DIHYDROCHLORIDE HISTAMINE LAURETH-7 C13-14 ISOPARAFFIN HELIANTHUS ANNUUS (SUNFLOWER) SEED SODIUM POLYACRYLATE (8000 MW) BOSWELLIA SERRATA WHOLE GLYCYRRHIZA GLABRA (LICORICE) ROOT BROMELAINS NIACIN TURMERIC ASCORBIC ACID ARNICA MONTANA FLOWER ALOE BARBADENSIS LEAF MAGNESIUM SULFATE TOCOPHEROL POLYACRYLAMIDE (10000 MW) CHAMOMILE DIMETHYL SULFONE"],"stop_use":["Warnings For external use only. Do not use on wounds or damaged skin or if you are allergic to ingredients in this product. When using this product: avoid contact with eyes. If product gets into eyes, rinse thoroughly with water. Do not bandage tightly or use a heating pad. Stop use and ask doctor if: rash appears. Condition worsens. If symptoms persist for more than 7 days or if symptoms clear up and occur again within a few days. If pregnant or breast feeding, ask a health professional before use."],"version":"1","warnings":["Warnings Section For external use only. Do not use on wounds or damaged skin or if you are allergic to ingredients in this product. When using this product: avoid contact with eyes. If product gets into eyes, rinse thoroughly with water. Do not bandage tightly or use a heating pad. Stop use and ask doctor if: rash appears. Condition worsens. If symptoms persist for more than 7 days or if symptoms clear up and occur again within a few days. If pregnant or breast feeding, ask a health professional before use."],"when_using":["Uses For temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains and bruises. When using this product: avoid contact with eyes. If product gets into eyes, rinse thoroughly with water. Do not bandage tightly or use a heating pad.","Directions For Use by Adults and Children over 12 years. Apply a thin layer to pain site and massage until thoroughly absorbed into skin. Apply no more than 3 to 4 times daily. Children 12 years or younger consult a physician"]}