ENVIROPURE ANTIBACTERIAL HAND SANITIZER MAXIMUM STRENGTH (ALCOHOL-FREE)- benzalkonium chloride liquid

EnviroPure Antibacterial Hand Sanitizer Maximum Strength (Alcohol-Free) by

Drug Labeling and Warnings

EnviroPure Antibacterial Hand Sanitizer Maximum Strength (Alcohol-Free) by is a Otc medication manufactured, distributed, or labeled by Windmill Health Products, LLC, Cemi International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial and First aid antiseptic

Uses

• For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.
• For wound sanitizing to help prevent bacterial contamination in cuts, scrapes, burns, lacerations and skin infections.

Warnings

For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Discontinue use if irritation or redness develops. If condition persists for more than 72 hours consult a doctor.

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

Directions

• Pump onto hands as needed. Rub briskly together until dry.
• Pump onto wounds 3 times a day after cleaning. Allow foam to dissipate. Wipe excess with sterile gauze. May be bandaged once dry.

Inactive ingredients

ionized water, urea

SPL UNCLASSIFIED SECTION

Distributed by: Windmill Health Products®
10 Henderson Drive
West Caldwell, NJ 07006

PRINCIPAL DISPLAY PANEL - 1 gal Bottle Label

ENVIROPURE™

ANTIBACTERIAL

HAND
SANITIZER

MAXIMUM STRENGTH

Eliminates 99.99% of Germs

alcohol-free
triclosan-free & fragrance-free

BENZALKONIUM CHLORIDE 0.13%

BAC-D
BACTERIAL DEFENSE®

128 fl. oz. (1 gal)

INGREDIENTS AND APPEARANCE

ENVIROPURE ANTIBACTERIAL HAND SANITIZER MAXIMUM STRENGTH (ALCOHOL-FREE) 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74154-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	Benzalkonium Chloride	0.13 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
urea (UNII: 8W8T17847W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74154-004-10	3785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/23/2020

Labeler - Windmill Health Products, LLC (831136267)

Establishment
Name	Address	ID/FEI	Business Operations
Cemi International		015038336	MANUFACTURE(74154-004)