CARLOTTA INSTANT HAND SANITIZER- alcohol gel Guangzhou Zuofun Cosmetics Co., Ltd Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- Carlotta Instant Hand Sanitizer Drug Facts Active ingredient Ethyl alcohol 75%(V/V) Purpose Antiseptic Use for handwashing to decrease bacteria on the hand Warnings For external use only.. Flammable, keep away from fire or flame. Do not use in the eyes. Stop use and ask a doctor if irritation and redness develop condition persists for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions Wet hands thoroughly with product and allow to Other Information Store between 59-86°F (15-30°C) Avoid freezing and excessive heat above 104°F (40°C) Inactive ingredients Carbomer, Glycerol, Triethanolamine, Water. Package Labeling: 250ml Label Package Labeling: 500ml Label2 Package Labeling: 4.9L Label 4.9 Package Labeling: 300ml Bottle2 Package Labeling: 100ml Bottle3 Package Labeling: 60ml Bottle4 Package Labeling: Tube, 60ml Bottle5 Package Labeling:Go, 60ml Bottle6 Package Labeling: 960ml Bottle Label960 Package Labeling:120ml Label120 Package Labeling:236ml Label236 Package Labeling:3.8L Label3.8 CARLOTTA INSTANT HAND SANITIZER alcohol gel Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77027-000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.75 mL in 1 mL Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77027-000-01 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2020 2 NDC:77027-000-02 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2020 3 NDC:77027-000-03 4900 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/24/2020 4 NDC:77027-000-04 300 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/24/2020 5 NDC:77027-000-05 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/24/2020 6 NDC:77027-000-06 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/24/2020 7 NDC:77027-000-07 60 mL in 1 TUBE; Type 0: Not a Combination Product 05/24/2020 8 NDC:77027-000-08 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/24/2020 9 NDC:77027-000-09 960 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/18/2020 10 NDC:77027-000-10 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/13/2020 11 NDC:77027-000-11 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/13/2020 12 NDC:77027-000-12 3800 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/01/2020 Labeler - Guangzhou Zuofun Cosmetics Co., Ltd (530135094) Revised: 7/2020