Label: ANTIBACTERIAL HAND WASH- benzalkonium chloride 0.13% liquid
- NDC Code(s): 69790-488-08
- Packager: Uline
- 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 September 26, 2022
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- Active ingredient
- Purpose
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- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
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- Inactive ingredients
- SPL UNCLASSIFIED SECTION
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL HAND WASH
benzalkonium chloride 0.13% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69790-488 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.313 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV) SODIUM CHLORIDE (UNII: 451W47IQ8X) myristamidopropylamine oxide (UNII: 3HSF539C9T) GLYCERIN (UNII: PDC6A3C0OX) DISTEARETH-75 ISOPHORONE DIISOCYANATE (UNII: 5365FJ30SC) PEG-150 distearate (UNII: 6F36Q0I0AC) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE SODIUM (UNII: MP1J8420LU) SULISOBENZONE (UNII: 1W6L629B4K) SODIUM BENZOATE (UNII: OJ245FE5EU) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69790-488-08 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/27/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/27/2018 Labeler - Uline (039612668) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(69790-488) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(69790-488)