BYOTROL ANTIBACTERIAL FOAMING HAND SANITIZER- benzalkonium chloride liquid

Byotrol Antibacterial Foaming Hand Sanitizer by

Drug Labeling and Warnings

Byotrol Antibacterial Foaming Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Byotrol, Inc., Bayscience Formulators Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Benzalkonium Chloride 0.13%

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

Pump a small amount of foam onto hands

Rub thoroughly over all surfaces of both hands

Rub hands together briskly until dry

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

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)

INGREDIENTS AND APPEARANCE

BYOTROL ANTIBACTERIAL FOAMING HAND SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42719-346
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42719-346-50	500 mL in 1 BOTTLE
2	NDC: 42719-346-51	210 mL in 1 BOTTLE
3	NDC: 42719-346-99	50 mL in 1 BOTTLE
4	NDC: 42719-346-06	1250 mL in 1 CARTRIDGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/08/2013

Labeler - Byotrol, Inc. (084600340)

Establishment
Name	Address	ID/FEI	Business Operations
Bayscience Formulators Inc.		162930544	manufacture(42719-346)