{"active_ingredient":["Active Ingredient(s) Isopropyl Alcohol 75% v/v. Purpose: Antiseptic Alcohol 80% v/v. Purpose: Antiseptic Back ingredients label Front product label 80 percent alcohol back 80 percent alcohol front"],"do_not_use":["Do not use in children less than 2 months of age on open skin wounds Back ingredient label with warning 80% alcohol back label 750ml 80 percent front label"],"dosage_and_administration":["Directions Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing. Back ingredient label dosage 750ml 80 alcohol back 750ml 80 alcohol front"],"effective_time":"20200418","id":"a3928c7b-85dc-3d1e-e053-2a95a90a425c","inactive_ingredient":["Inactive ingredients glycerin, hydrogen peroxide, purified water USP Back ingredient label inactive ingredients 750ml 80 percent alcohol back label 750 ml 80% alcohol front label"],"indications_and_usage":["Use Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. Back product ingredients label Front Product label 80 percent alcohol back label 750 ml 80 percent alcohol front label"],"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. Back ingredient label keep out of reach 750ml 80% alcohol back 750ml 80% front label"],"openfda":{},"package_label_principal_display_panel":["Package Label - Principal Display Panel 375 ml NDC: 74357-0001-1 750 ml NDC: 74357-0002-2 back ingredients label Front package label 750 80 percent alcohol back label 750 ml 80 percent front"],"purpose":["Purpose Antiseptic, Hand Sanitizer Antiseptic, Hand Sanitizer Back ingredient label Front product image 80 percent Alcohol back label 80 percent alcohol front label"],"recent_major_changes":["Indications and Usage Back label image description corrected. Image was deleted and re-uploaded because it was undefined. Inserted image above content wording. Deleted and re-uploaded Dosage and Administration Pressed enter to get rid of a bullet point so I could insert image Indications and Usage 4/2020 - added new packaging label for 750ml 80% alcohol Dosage and administration 4/2020 - added new packaging label for 750ml 80% alcohol"],"set_id":"a23a15c4-1b08-e7ac-e053-2995a90ad31b","spl_product_data_elements":["Hand Sanitizer Dr Montys Germ Buster GLYCERIN HYDROGEN PEROXIDE WATER ALCOHOL ALCOHOL Hand Sanitizer Isopropyl Alcohol GLYCERIN HYDROGEN PEROXIDE WATER ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL"],"spl_unclassified_section":["This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry . The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations: Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerol (1.45% v/v). Hydrogen peroxide (0.125% v/v). Sterile distilled water or boiled cold water. The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product."],"stop_use":["Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Back ingredient label stop use 80% alcohol back 80% alcohol front"],"storage_and_handling":["Other information Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F) Back ingredient label other information 750ml 80% Alcohol back 750ml 80% Alcohol front"],"version":"2","warnings":["Warnings For external use only. Flammable. Keep away from heat or flame Back product ingredient label 750 ml 80% alcohol back label 80% alcohol front label"],"when_using":["When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Back ingredient label when using 750ml 80% alcohol back label"]}