WSNA HAND SANITIZER - benzalkonium chloride liquid 
Byotrol, 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 0.13%

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 the 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

Pump a small amount of foam onto hands

Rub thoroughly over all surfaces of both hands

Rub hands together briskly until dry

Inactive ingredients:

Water, Cetrimonium Chloride, Laurtrimonium Chloride, Glycereth-17 Cocoate, Dihydroxyethyl Cocamine Oxide, Polyaminopropyl Biguanide, C8-10 Alkyl Polyglucoside, C12-15 Pareth-7, Citric Acid, Dimethicone

WSNA

Washington State

Nurses Association

byotrol

ALCOHOL-FREE

ANTIBACTERIAL FOAMING

Hand Sanitizer

Powerful, Long-Lasting and Gentle

Net Contents: 1.69 fl. Oz. (50ml)

container label


WSNA HAND SANITIZER 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42719-347
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
POLIHEXANIDE (UNII: 322U039GMF)  
CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)  
C12-15 PARETH-7 (UNII: 3XY03A79QH)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42719-347-9950 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/22/2014
Labeler - Byotrol, Inc. (084600340)
Establishment
NameAddressID/FEIBusiness Operations
Clean Advantage Inc178123832manufacture(42719-347)

Revised: 1/2014
Document Id: 390ab5f1-e771-4d12-8f2a-8271a50f8403
Set id: 4313099a-231c-4d92-b3f6-7ea5748fbfb8
Version: 1
Effective Time: 20140122
 
Byotrol, Inc.