PROCLEAN- benzalkonium chloride solution

ProClean by

Drug Labeling and Warnings

ProClean by is a Otc medication manufactured, distributed, or labeled by Ecolab Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 INGREDIENT

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

Questions? call 1-866-781-8787

Representative Label and Principal Display Panel

ProClean

Antibacterial

Foaming Hand Soap

Active ingredient Benzalkonium chloride 0.5%

6101554

750 mL

(25.3 US FL OZ)

767783/5400/0816

Ecolab · 370 Wabasha Street N ·

St Paul MN 55102-1390 USA ·

tel: 1 800 35 CLEAN (352 5326)

© 2016 Ecolab USA Inc. · All rights reserved | Todos los derechos reservados

Made in United States | Hecho en Estados Unidos

www.ecolab.com

INGREDIENTS AND APPEARANCE

PROCLEAN 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47593-579
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47593-579-41	750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/17/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/17/2016

Labeler - Ecolab Inc. (006154611)