{"active_ingredient":["Active Ingredient Lidocaine 4%"],"dosage_and_administration":["Directions Use only as directed. Adults & children 12 years or older: apply evenly to affected area not more than 3-4 x daily. For children under 12 years, consult with doctor for recommendations. Change in heading as requested after review of draft The Indications and Directions section was renameded to Dosage and Administration. This was noted as required 34068-7 This change was made on 7/21/2022 as directed. 07/26/22-- As per validation request, changed Directions to come under Dosage and Administration."],"effective_time":"20251031","id":"42797949-24f3-3b3b-e063-6394a90a2b06","inactive_ingredient":["Arnica Montana flower extract, cetearyl alcohol, cetyl ester waxes, cyclopentasiloxane, disodium EDTA, ethoxydiglycol, fragrance, Helianthus annuus (sunflower) oil, Lavandula Angustifolio (lavender) oil, methylparaben, PEG40 hydrogenated caster oil, poly(acrylic acid) 2-propionic acid homopolymer, propylene glycol, propylparaben, tetrahydrocurcumin, tocopherol acetate, triethanolamine, water."],"indications_and_usage":["Uses for temporary relief of pain & inflammation"],"keep_out_of_reach_of_children":["Precautions Concerning Children Keep out of reach of children."],"openfda":{},"package_label_principal_display_panel":["Package Label and Principal Display Panel Vonaflex NDC 36590-6451-03 front & back label NDC-3690-6461-03"],"purpose":["Uses For temporary relief of pain & inflammation Uses for temporary relief of pain & inflammation"],"questions":["Questions and Comments www.optimallabortories.com (212) 535-1700"],"recent_major_changes":["Change in heading as requested after review of draft The Indications and Directions section was renameded to Dosage and Administration. This was noted as required 34068-7 This change was made on 7/21/2022 as directed. 07/26/22-- As per validation request, changed Directions to come under Dosage and Administration."],"set_id":"dd30ccaf-d239-9d82-e053-2a95a90a6e84","spl_product_data_elements":["Vonaflex Lidocaine Lotion METHYLPARABEN EDETATE DISODIUM PROPYLPARABEN WATER SUNFLOWER OIL CARBOMER 940 LAVENDER OIL POLYOXYL 40 HYDROGENATED CASTOR OIL PROPYLENE GLYCOL DIETHYLENE GLYCOL MONOETHYL ETHER CETYL ESTERS WAX CETOSTEARYL ALCOHOL TETRAHYDRODIFERULOYLMETHANE TROLAMINE .ALPHA.-TOCOPHEROL ACETATE CYCLOMETHICONE 5 FRAGRANCE LAVENDER ROSE ORC1004596 ARNICA MONTANA FLOWER WATER LIDOCAINE LIDOCAINE"],"storage_and_handling":["Other Information: Store at 20 o - 25 o C (68 o - 77 o F),. Protect from freezing or storing in direct sunlight."],"version":"6","warnings":["For External use only. Do not use: on wounds, raw surfaces or blistered areas, with a heating pad, or if allergic to product ingredients When using this product: Avoid eye contact; do not use excessive amounts; do not exceed recommended dosage unless directed by doctor; do not bandage applied area. Stop and ask doctor if: an allergic reaction occurs; condition worsens or does not improve within 7 days. If pregnant or breast-feeding: consult with doctor before use. if swallowed, get medical help or contact a Poison Control Center. Precautions Concerning Children Keep out of reach of children."]}