{"active_ingredient":["Active Ingredient(s) Sanitize 75 (NDC# 76748-0275 and Sanitize NT-75 (NDC# 76748-0475) Isopropyl Alcohol 75% v/v. Purpose: Antiseptic Sanitize 80 (NDS# 76748-0180) and Sanitize NT-80 (NDC# 76748-0380) Ethanol 80% v/v. Purpose Antiseptic"],"do_not_use":["Do not use in children less than 2 months of age on open skin wounds"],"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."],"effective_time":"20200902","id":"ae5a138a-bcb1-08dd-e053-2a95a90a0478","inactive_ingredient":["Inactive ingredients glycerin, hydrogen peroxide, purified water USP"],"indications_and_usage":["Use Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."],"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 SANITIZE 80 76748-0180-1 SANITIZE 80 76748-0180-2 SANITIZE 80 76748-0180-3 SANITIZE NT-80 76748-0380-1 SANITIZE NT-80 76748-0380-2 SANITIZE NT-80 76748-0380-3 SANITIZE 75 76748-0275-1 SANITIZE 75 76748-0275-2 SANITIZE 75 76748-0275-3 SANITIZE NT 75 76748-0475-1 SANITIZE NT 75 76748-0475-2 SANITIZE NT 75 76748-0475-3"],"purpose":["Purpose Antiseptic, Hand Sanitizer"],"set_id":"a61a7a37-7743-9376-e053-2a95a90aeb3e","spl_product_data_elements":["Sanitize NT-75 Hand Sanitizer HYDROXYETHYL CELLULOSE, UNSPECIFIED TROLAMINE FD&C BLUE NO. 1 ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL GLYCERIN WATER Sanitize 80 Hand Sanitizer GLYCERIN WATER FD&C BLUE NO. 1 ALCOHOL ALCOHOL BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) TROLAMINE Sanitize NT-80 Hand Sanitizer TROLAMINE WATER FD&C BLUE NO. 1 GLYCERIN HYDROXYETHYL CELLULOSE, UNSPECIFIED ALCOHOL ALCOHOL Sanitize 75 Hand Sanitizer BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) FD&C BLUE NO. 1 GLYCERIN WATER ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL TROLAMINE"],"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: Sanitize 80 a. Ethanol (80%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. b. Glycerol (0.725% v/v). c. Copolymer (6 % v/v). d. Trolamine (0.3 % v/v). e. FD&C Blue No.1 (0.00018 % v/v). f. 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. Sanitize NT-80 a. Ethanol (80%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. b. Glycerol (0.725% v/v). c. Hydroxyethyl Cellulose (1.8 % v/v). d. Trolamine (0.3 v/v). e. FD&C Blue No.1 (0.00018 % v/v). e. 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. Sanitize 75 a. 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. b. Glycerol (0.725 % v/v). c. Copolymer (8.2 % v/v). d. Trolamine (1 % v/v) e. FD&C Blue No.1 (0.00018 % v/v). f. 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. Sanitize NT-75 a. 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. b. Glycerol (0.725% v/v). c. Hydroxyethyl Cellulose (1.8 % v/v). d. Trolamine (0.3 v/v). e. FD&C Blue No.1 (0.00018 % v/v). e. 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."],"storage_and_handling":["Other information Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)"],"version":"2","warnings":["Warnings For external use only. Flammable. Keep away from heat or flame"],"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."]}