Label: PRIMORY ANTIBACTERIAL PLUM FOAM HANDWASH- benzalkonium chloride liquid
- NDC Code(s): 21749-454-08, 21749-454-89, 21749-454-90, 21749-454-97
- Packager: GOJO Industries, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated August 10, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PRIMORY ANTIBACTERIAL PLUM FOAM HANDWASH
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21749-454 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride 0.5 mg in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) PROPANEDIOL (UNII: 5965N8W85T) Glycerin (UNII: PDC6A3C0OX) Cocamidopropyl Betaine (UNII: 5OCF3O11KX) PEG-80 Sorbitan Laurate (UNII: 239B50Y732) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Ethylhexylglycerin (UNII: 147D247K3P) Lauramine Oxide (UNII: 4F6FC4MI8W) POLYQUATERNIUM-10 (10000 MPA.S AT 2%) (UNII: PI1STR9QYH) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21749-454-08 236 mL in 1 PACKAGE; Type 0: Not a Combination Product 06/14/2017 2 NDC:21749-454-97 700 mL in 1 PACKAGE; Type 0: Not a Combination Product 06/14/2017 12/31/2023 3 NDC:21749-454-89 1200 mL in 1 PACKAGE; Type 0: Not a Combination Product 06/14/2017 4 NDC:21749-454-90 1250 mL in 1 PACKAGE; Type 0: Not a Combination Product 06/14/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 06/14/2017 Labeler - GOJO Industries, Inc. (004162038) Establishment Name Address ID/FEI Business Operations GOJO Industries, Inc. 036424534 manufacture(21749-454) Establishment Name Address ID/FEI Business Operations GOJO Industries, Inc. 088312414 manufacture(21749-454) , label(21749-454) , pack(21749-454)