NDC | 11344-456-07, 11344-456-08, 11344-456-16, 11344-456-20, 11344-456-43, 11344-456-44, 11344-456-45, 11344-456-49, 11344-456-76, 11344-456-86, 11344-456-96 |
Set ID | 64c59c8a-bde6-4a7b-b509-ed06c9ee97c5 |
Category | HUMAN OTC DRUG LABEL |
Packager | Vi-Jon, LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART333A |
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach children
- Directions
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- principal display panel
- principal display panel
- principal display panel
-
INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11344-456 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL .70 mL in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) PEG-8 DIMETHICONE (UNII: GIA7T764OD) MEADOWFOAMAMIDOPROPYL BETAINE (UNII: HNV0L650LG) GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11344-456-45 1150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/10/2016 2 NDC:11344-456-07 750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/10/2016 3 NDC:11344-456-16 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/10/2016 4 NDC:11344-456-96 221 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/10/2016 5 NDC:11344-456-49 443 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package 06/10/2016 6 NDC:11344-456-43 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/10/2016 7 NDC:11344-456-76 500 mL in 1 BAG; Type 0: Not a Combination Product 10/26/2018 8 NDC:11344-456-44 532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/10/2016 9 NDC:11344-456-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/10/2016 10 NDC:11344-456-08 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/10/2016 11 NDC:11344-456-20 44 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/10/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/10/2016 Labeler - Vi-Jon, LLC (150931459) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 150931459 manufacture(11344-456) Establishment Name Address ID/FEI Business Operations Avmor 202107827 manufacture(11344-456) Establishment Name Address ID/FEI Business Operations Chemisphere Corporation 071957146 manufacture(11344-456)