{"active_ingredient":["Active Ingredient Menthol 5%"],"dosage_and_administration":["Directions • Remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle • Carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area • Once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area Children 12 years or younger, ask a doctor"],"effective_time":"20240125","health_care_provider_letter":["Other Information Responsible pharmacist: Mauricio R. Marante - CRF-SP 28.847. ANVISA Registration No. 81807850002 Manufactured by: Lead Chemical Company, Ltd., 77-3 Himata, Toyama City, 930-0912. Toyama, Japan. Packaged by: Chattem, Inc., 1715 West 38th Street, Chattanooga, Tennessee, 37409. United States. Imported by: Sanofi Medley Farmaceutica Ltda. Rua Conde domingos Papaiz, 413 - Suzano - SP - CEP 08613- 901. CNPJ 10.588.595/0010-92."],"id":"c9cb8c59-1b93-4fa8-88dc-c2dc434b2f8f","inactive_ingredient":["Inactive Ingredients acrylic acid, aluminum hydroxide, carmellose sodium, 2-ethylhexyl acrylate, glycerin, isopropyl myristate, methyl acrylate, nonoxynol-30, polyacrylate, polyacrylic acid, polysorbate 80, sorbitan sesquioleate, starch, talc, tartaric acid, titanium dioxide, water"],"indications_and_usage":["Uses Dorflex Icy Hot is indicated for bruises, traumas, muscle pains, cramps, torticollis and painful and inflammatory processes at large."],"instructions_for_use":["Precautions • Do not wear the same patch for more than 8 hours. • Do not wear more than 3 patches daily. • Store in ambient temperature. • Use each patch only once."],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed by accident, get medical help."],"openfda":{},"package_label_principal_display_panel":["Principal Display Panel - Small Dorflex ICY HOT ® Flexible Patch • Muscle pain • Bruises • Cramps • Torticollis Lasts up to 8 hours Contains 5 Patches in 1 Resealable Pouch Cut open pouch and remove pad Reseal pouch after opening Pouch Label - Small image-01","Principal Display Panel - Large Dorflex ICY HOT ® Flexible Patch • Muscle pain • Bruises • Cramps • Torticollis Lasts up to 8 hours Contains 5 Patches in 1 Resealable Pouch Cut open pouch and remove pad Reseal pouch after opening Pouch Label - Large image-03"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a doctor before use."],"purpose":["Purpose Topical analgesic"],"set_id":"3d69bc86-aa79-4f06-ab39-59aa41f82b54","spl_product_data_elements":["Dorflex Icy Hot Flexible, Small Menthol MENTHOL MENTHOL ACRYLIC ACID ALUMINUM HYDROXIDE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 2-ETHYLHEXYL ACRYLATE GLYCERIN ISOPROPYL MYRISTATE METHYL ACRYLATE NONOXYNOL-30 SODIUM POLYACRYLATE (2500000 MW) POLYACRYLIC ACID (250000 MW) POLYSORBATE 80 SORBITAN SESQUIOLEATE STARCH, CORN TALC TARTARIC ACID TITANIUM DIOXIDE WATER Dorflex Icy Hot Flexible, Large Menthol MENTHOL MENTHOL ACRYLIC ACID ALUMINUM HYDROXIDE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 2-ETHYLHEXYL ACRYLATE GLYCERIN ISOPROPYL MYRISTATE METHYL ACRYLATE NONOXYNOL-30 POLYACRYLIC ACID (250000 MW) POLYSORBATE 80 SODIUM POLYACRYLATE (2500000 MW) SORBITAN SESQUIOLEATE STARCH, CORN TALC TARTARIC ACID TITANIUM DIOXIDE WATER"],"stop_use":["Stop use and ask a doctor if • Condition worsens. • Irritation or redness develops. • Symptoms persist for more than 7 days or clear up and occur again within a few days."],"version":"6","warnings":["Warnings For external use only For use in adults and children over 12 years. When using this product • Use only as directed. • Do not use with a heating pad. • Avoid contact with eyes and mucous membranes. • Do not apply to wounds or damaged, broken or irritated skin. Stop use and ask a doctor if • Condition worsens. • Irritation or redness develops. • Symptoms persist for more than 7 days or clear up and occur again within a few days. If pregnant or breast-feeding, ask a doctor before use. Keep out of reach of children. If swallowed by accident, get medical help."],"when_using":["When using this product • Use only as directed. • Do not use with a heating pad. • Avoid contact with eyes and mucous membranes. • Do not apply to wounds or damaged, broken or irritated skin."]}