4 SURE PLUS E3 INSTANT FOAM HAND SANITIZER- benzalkonium chloride liquid

4 SURE Plus E3 Instant Foam Hand Sanitizer by

Drug Labeling and Warnings

4 SURE Plus E3 Instant Foam Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by DevMar Products LLC, Maxpax LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Benzalkonium Chloride 0.1%

PURPOSE

Purpose

Antimicrobial

INDICATIONS & USAGE

Uses

For hand sanitizing to decrease bacteria on the skin

Recommended for repeated use

WARNINGS

Warnings

For external use only

When using this product avoid contact with eyes.

In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

Wash hands with soap and water

Rinse with potable water

Pump a small amount of foam into palm of hand

Rub thoroughly over all surfaces of both hands

Rub hands together briskly until dry

INACTIVE INGREDIENT

Inactive ingredients

Water, cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, citric acid

PRINCIPAL DISPLAY PANEL

4 SURE Plus E3 Instant Foam Hand Sanitizer

Hand Sanitizer

Alcohol Free

Kills up to 99.9%

of germs on Hands

Refreshing and Soft on Skin

Acceptable for use in food processing facilities

NSF

Nonfood Compounds

Program Listed E3

#147444

550 mL (18.6 fl. oz) Made in the U.S.A.

INGREDIENTS AND APPEARANCE

4 SURE PLUS E3 INSTANT FOAM HAND SANITIZER  
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54410-001
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)
GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54410-001-01	50 mL in 1 BOTTLE, PLASTIC
2	NDC: 54410-001-02	210 mL in 1 BOTTLE, PLASTIC
3	NDC: 54410-001-03	550 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/10/2013

Labeler - DevMar Products LLC (809038255)

Establishment
Name	Address	ID/FEI	Business Operations
Maxpax LLC		027109390	manufacture(54410-001)