PROCLEAN- 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

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 physician 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

Other information

Inactive ingredients water (aqua), cocamine oxide, hexylene glycol, PEG-180, glycerin, hydroxyethylcellulose, cocamidopropyl PG-dimonium chloride phosphate, phenoxyethanol, myristamide DIPA, myristamine oxide, methyl gluceth-20, glyceryl caprylate/caprate, alcohol, PEG-12 dimethicone, citric acid, polyquaternium-7, fragrance, potassium hydroxide, blue 1

Questions? call 1-866-781-8787

Representative Label and Principal Display Panel

PROCLEAN

ADVANCED

ANTIBACTERIAL

HAND SOAP

Antibacterial liquid hand soap

Active ingredient: Benzalkonim chloride 0.5%

6102017

3.78 L (1 US GAL)

For more ingredient information visit: www.shamrockfoodservice.com/proclean

This product may be patented

For questions or comments, call 1-866-444-7450.

Manufactured by

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

© 2018  Ecolab USA Inc. · All rights reserved

774470/5400/1018

Distributed by Shamrock Foods

Phoenix, AZ

representative label

PROCLEAN 
benzalkonium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47593-602
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCAMINE OXIDE (UNII: QWA2IZI6FI)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MYRISTIC DIISOPROPANOLAMIDE (UNII: 17DN142CTK)  
MYRISTAMINE OXIDE (UNII: J086PM3RRT)  
METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)  
ALCOHOL (UNII: 3K9958V90M)  
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47593-602-113780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/29/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/29/2018
Labeler - Ecolab Inc. (006154611)

Revised: 1/2019
Document Id: e8822cdf-6cc6-4dc2-bb6f-a4c86c42c2a5
Set id: 60da90e4-3467-4aea-9c44-09a9ef718995
Version: 1
Effective Time: 20190115
 
Ecolab Inc.