Label: ECOLAB- benzalkonium chloride solution
- NDC Code(s): 63146-123-10
- Packager: Kay Chemical Company
- 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 December 8, 2022
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- Active ingredient
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Principal display panel and representative container
NDC 63146-123-10
Foaming Hand Sanitizer
KEEP OUT OF REACH OF CHILDREN
FOR INSTITUTIONAL USE ONLY
Benzalkonium chloride 0.1%
Net Contents:
42 US fl oz (1250 ml)
FRSUSA 764026/8001/1020
Distributed by:
Kay Chemical Company · 8300 Capital Drive
Greensboro, NC 27409-9790 USA Customer Service: (800) 529-5458
©2020 Kay Chemical Company
All rights reserved · Made in USA
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INGREDIENTS AND APPEARANCE
ECOLAB
benzalkonium chloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63146-123 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOPROPYL ALCOHOL (UNII: ND2M416302) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63146-123-10 1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 02/01/2016 Labeler - Kay Chemical Company (003237021)