Label: ECOLAB INC.- benzalkonium chloride solution
- NDC Code(s): 47593-514-62
- Packager: Ecolab 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 July 13, 2023
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- Active ingredient
- Purpose
- Uses
- Warnings
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Directions: Concentrated Solution
- do not mix with anything except for potable water
- use only provided bottles for dilution and dispensing of ready-to-use product
- remove cap, open dispenser door, place bottle into position, and close dispenser door
- fill hand sanitizer bottle with solution from dispenser
- place bottle into a Nexa dispenser for use
- Directions: Ready-To-Use Solution
- Other information
- INACTIVE INGREDIENT
- QUESTIONS
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Principal Display Panel and Representative Label
ECOLAB® 6100874
FACILIPRO
Concentrated Foam Hand Sanitizer
1.3 L (44 US FL OZ)
Active ingredient: Benzalkonium chloride, 0.89%
Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA · tel: 1 800 35 CLEAN (352 5326)
© 2018 Ecolab USA Inc. · All rights reserved
Made in U.S.A.
www.ecolab.com · 759261/5401/1018
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INGREDIENTS AND APPEARANCE
ECOLAB INC.
benzalkonium chloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47593-514 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 8.9 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM BENZOATE (UNII: OJ245FE5EU) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 40 (UNII: WZB9127XOA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47593-514-62 1300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/02/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 03/02/2015 Labeler - Ecolab Inc. (006154611)