{"active_ingredient":["Active Ingredient Alcohol 71% v/v"],"dosage_and_administration":["Directions Place enough product in your palm to thoroughly cover your hands Rub hands together briskly until dry Children under 6 years of age should be supervised while using this product"],"effective_time":"20200627","id":"a89b894e-0786-db43-e053-2a95a90a46e9","inactive_ingredient":["Inactive ingredients Water, Aloe Vera, Isopropyl Alcohol, Sepimax Zen"],"indications_and_usage":["Uses Hand Sanitizer that reduces bacteria on the skin including bacteria that may cause disease. Intended for repeated use."],"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":{},"package_label_principal_display_panel":["Package Label - Principal Display Panel These labels are representative of all listed dosage forms: 4oz Drug Facts Label 4oz Label Front 12oz Product Label"],"purpose":["Purpose ANTISEPTIC"],"questions":["Questions or comments? Call 1-844-333-2133 Monday-Friday 9:00am - 5:00pm"],"set_id":"a89b7a62-e646-919b-e053-2a95a90a9e68","spl_product_data_elements":["Hand Sanitizer Ethyl Alcohol ALOE VERA LEAF WATER ALCOHOL ALCOHOL ISOPROPYL ALCOHOL AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)"],"spl_unclassified_section":["This is a hand sanitizer manufactured according to 21 CFR part 210, 211, 333, and 330*.* In Health Care Antiseptic Final Rule: Finalizes rulemaking for healthcare antiseptics, a final monograph determination was not made for three active ingredients: Isopropyl alcohol 70-91.3 percent, Benzalkonium chloride, and Alcohol (ethyl alcohol) 60 to 95 percent. These active ingredients were classified as Category III. Therefore, according to 21 USC 355h, this hand sanitizer is not required to be the subject of an application approved under section 355 of Title 21 because this hand sanitizer is: (i) classified in category III for safety or effectiveness in the preamble of a proposed rule establishing a tentative final monograph that is the most recently applicable proposal or determination for such drug issued under part 330 of title 21, Code of Federal Regulations; (ii) in conformity with- (I) the conditions of use, including indication and dosage strength, if any, described for the Health care personnel hand rub with the active ingredient Alcohol 60 to 95 percent in such preamble or in an applicable subsequent proposed rule; (II) the proposed requirements for drugs classified in such tentative final monograph in category I in the most recently proposed rule establishing requirements related to such tentative final monograph and in any final rule establishing requirements that are applicable to the drug; and (III) the general requirements for nonprescription drugs and conditions or requirements under subsection (b) or (k) of 21 USC 355h; and (iii) in a dosage form that, immediately prior to March 27, 2020, had been used to a material extent and for a material time under section 321(p)(2) of Title 21. The hand sanitizer is formulated using only the following ingredients: Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (71%, volume/volume (v/v)) in an aqueous solution denatured with Isopropanol according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Aloe Vera Leaf. AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) Sterile distilled water or boiled cold water."],"stop_use":["Stop use and ask a doctor if irritation or rash appears and lasts"],"storage_and_handling":["Other information Do not store above 110 °F (43 °C) May discolor certain fabrics or surfaces"],"version":"1","warnings":["Warnings Flammable. Keep away from fire or flame. For external use only. When using this product do not use near the eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash appears and lasts Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away."],"when_using":["When using this product do not use near the eyes. In case of contact, rinse eyes thoroughly with water."]}