NDC | 43097-457-10, 43097-457-12, 43097-457-14, 43097-457-18 |
Set ID | f0726bdd-9d2b-4383-af10-e2e0c5460e1e |
Category | HUMAN OTC DRUG LABEL |
Packager | People's Janitorial Supply |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART333E |
- Drug Facts Box OTC-Active Ingredient Section
- Drug Facts Box OTC-Indications & Usage Section
- Drug Facts Box OTC-Warnings Section
- Drug Facts Box OTC-Purpose Section
- Drug Facts Box-OTC When Using Section
- Drug Facts Box-OTC Stop Use Section
- Drug Facts Box-OTC Keep Out Of Reach Of Children Section
- Drug Facts Box-OTC Dosage & Administration Section
- Drug Facts Box-OTC Inactive Ingredient Section
- Puri-San Plus Instant Hand Sanitizer
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INGREDIENTS AND APPEARANCE
PURI-SAN PLUS INSTANT HAND SANITIZER
benzealkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43097-457 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) DMDM HYDANTOIN (UNII: BYR0546TOW) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43097-457-10 1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 02/20/2019 2 NDC:43097-457-18 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/20/2019 3 NDC:43097-457-14 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/20/2019 4 NDC:43097-457-12 1000 mL in 1 BAG; Type 0: Not a Combination Product 02/20/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 02/20/2019 Labeler - People's Janitorial Supply (057299729) Registrant - ABC Compounding Co., Inc. (003284353) Establishment Name Address ID/FEI Business Operations ABC Compounding Co., Inc. 003284353 manufacture(43097-457)