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

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.

----------

Drug Facts

Active ingredient

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Uses

For hand sanitizing to decrease bacteria on the skin

Recommended for repeated use

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.

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 ingredients

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

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.

container label


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 DEA Schedule     
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)

Revised: 3/2013
Document Id: dd133d21-b8a2-40e5-b31d-fd8f272adbdf
Set id: e413c4a6-c372-4ea2-801f-423b626e7504
Version: 2
Effective Time: 20130313
 
DevMar Products LLC