FACILIPRO- benzalkonium chloride solution
Ecolab Inc.

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.

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Drug Facts

Active Ingredient

Benzalkonium chloride 0.5%

Purpose

Antiseptic handwash

Uses

for handwashing to decrease bacteria on the skin

Warning

For external use only

Do not use

in eyes

When using the product

if in eyes, rinse promptly and thoroughly with water
discontinue use if irritation and redness develop

Stop use and ask a doctor if skin irritation or redness occurs for more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

wet hands and apply foam
scrub hands and forearms
rinse thoroughly and dry

Other information

for additional information, see Safety Data Sheet (SDS)
for emergency medical information, in USA and Canada, call 1 800 328 0026

Inactive ingredients water (aqua), cocamine oxide, hexylene glycol, PEG-180, glycerin, cocamidopropyl PG-dimonium chloride phosphate, myristamine oxide, phenoxyethanol, polyquaternium 7, citric acid, myristamide DIPA, methyl gluceth-20, caprylic/capric glycerides, PEG-12 dimethicone, potassium hydroxide, fragrance, FD&C blue 1

Questions? call 1-866-781-8787

Representative Label and Principal Display Panel

ECOLAB®

6101091

FACILIPRO

Advanced Antibacterial Foaming Hand Soap

1250 mL (42.3 FL OZ)

Active Ingredient: Benzalkonium chloride 0.5%

Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA ·

tel: 1 800 35 CLEAN (352 5326)

Made in U.S.A.

www.ecolab.com

Representative label

FACILIPRO
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47593-566
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
MYRISTIC DIISOPROPANOLAMIDE (UNII: 17DN142CTK)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 900000 MW) (UNII: B70CUU14M9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MYRISTAMINE OXIDE (UNII: J086PM3RRT)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
WATER (UNII: 059QF0KO0R)
COCAMINE OXIDE (UNII: QWA2IZI6FI)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:47593-566-59	1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/23/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/23/2016

Labeler - Ecolab Inc. (006154611)

Revised: 5/2023

Document Id: c200fe86-abf5-4622-b669-d4d8f63358bd

Set id: 59580c40-ca37-4ac9-a2c3-ea86197cf68c

Version: 2

Effective Time: 20230518

Ecolab Inc.