{"active_ingredient":["Active Ingredient(s) Alcohol 80% v/v. Purpose: Antiseptic Back label"],"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":"20201228","id":"b78fb411-7db5-4b8b-e053-2995a90a3761","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":["80 mL Package Label - Principal Display Panel [Kuleana Spirits Inc. Logo] HAND SANITIZER ANTISEPTIC HAND RUB (Ethyl Alcohol Formulation for Consumer Use) ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION 80 ML (2.7 OZ) Non-sterile Solution FOR EXTERNAL USE ONLY NOT SAFE FOR CONSUMPTION Kuleana Rum Works 61-3270 Maluokalani St, B6 Kawaihae, HI 96743 Made in USA DATE:______ BATCH:_____ EXP:_____ 80 mL front label","750 mL Package label. Principal Display Panel [Kuleana Spirits Inc. Logo] HAND SANITIZER ANTISEPTIC HAND RUB (Ethyl Alcohol Formulation for Consumer Use) ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION 750 ML Non-sterile Solution FOR EXTERNAL USE ONLY NOT SAFE FOR CONSUMPTION Kuleana Rum Works 61-3270 Maluokalani St, B6 Kawaihae, HI 96743 Made in USA DATE:______ BATCH:_____ EXP:_____ NDC 75064-001-01 750 mL front label","47 mL Package label. Principal Display Panel [Kuleana Spirits Inc. Logo] HAND SANITIZER ANTISEPTIC HAND RUB (Ethyl Alcohol Formulation for Consumer Use) ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION 16 OZ Non-sterile Solution FOR EXTERNAL USE ONLY NOT SAFE FOR CONSUMPTION Kuleana Rum Works 61-3270 Maluokalani St, B6 Kawaihae, HI 96743 Made in USA DATE:______ BATCH:_____ EXP:_____ 16 oz front label","19 L Package label. Principal Display Panel [Kuleana Spirits Inc. Logo] HAND SANITIZER Ethanol Antiseptic 80% Topical Solution HAND SANITIZER FOR REPACKING Non-sterile Solution 5 Gal | 19 L Non-potable Manufactured by: Kuleana Rum Works 61-3270 Maluokalani St, B6 Kawaihae, HI 96743 888-429-6786 DUNS: 080996182 NDC 75064-001-06 5 Gal front label","200 L Package label. Principal Display Panel [Kuleana Spirits Inc. Logo] HAND SANITIZER ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION Hand Sanitizer for Repackaging Non-sterile Solution 55 Gal | 200 L Non-Potable Manufactured by: Kuleana Rum Works 61-3270 Maluokalani St, B6 Kawaihae, HI 96743 888-428-6786 DUNS: 090996182 NDC 75064-001-55 200 L front label"],"purpose":["Purpose Antiseptic, Hand Sanitizer"],"set_id":"a334d1bd-b693-73d2-e053-2a95a90a0c35","spl_product_data_elements":["Hand Sanitizer ALCOHOL GLYCERIN HYDROGEN PEROXIDE WATER ALCOHOL 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: Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (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."],"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."]}