BYOTROL ANTIBACTERIAL FOAMING 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 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

100%

Hygeine

Revolution

Byotrol

Alcohol Free

Kills Germs

Antibacterial Foaming

Hand Sanitizer

Powerful

No other FDA compliant hand antiseptic claims more.

Long Lasting

Foaming formula lasts, increasing wet contact time, to deliver the persistent performance Byotrol is known for.

Gentle

Alcohol Free Formula is hard on germs and soft on hands.

byotrol

Net Contents: 42.26 fl.Oz. (1,250ml)

container label


BYOTROL ANTIBACTERIAL FOAMING HAND SANITIZER 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42719-346
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)  
C12-15 PARETH-7 (UNII: 3XY03A79QH)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42719-346-50500 mL in 1 BOTTLE
2NDC:42719-346-51210 mL in 1 BOTTLE
3NDC:42719-346-9950 mL in 1 BOTTLE
4NDC:42719-346-061250 mL in 1 CARTRIDGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/08/2013
Labeler - Byotrol, Inc. (084600340)
Establishment
NameAddressID/FEIBusiness Operations
Bayscience Formulators Inc.162930544manufacture(42719-346)

Revised: 3/2013
Document Id: ca36ae2a-21c1-46a3-96cc-de95950d92ae
Set id: 1b45f435-dbcf-4560-a189-72c7ef48cfd9
Version: 1
Effective Time: 20130308
 
Byotrol, Inc.