BYOTROL HAND SANITIZER- benzalkonium chloride liquid

Byotrol Hand Sanitizer by

Drug Labeling and Warnings

Byotrol Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Advanced Hygienics LLC, Wisconsin Pharmacal Company. 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, Polyaminopropyl Biguanide, C8-10 Alkyl Polyglucoside, C12-15 Pareth-7, Dimethicone, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric Acid.

QUESTIONS

Questions? 1-866-443-4509

PRINCIPAL DISPLAY PANEL

byotrol

ANTIBACTERIAL FOAMING

HAND SANITIZER

ALCOHOL FREE  KILLS GERMS

POWERFUL

LONG LASTING

GENTLE

Net Contents: 16.9 FL OZ (500mL)

INGREDIENTS AND APPEARANCE

BYOTROL HAND SANITIZER  
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63002-002
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)
CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)
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: 63002-002-99	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/02/2014
2	NDC: 63002-002-50	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/25/2014
3	NDC: 63002-002-12	1250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/25/2014
4	NDC: 63002-002-75	9463 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/02/2014

Labeler - Advanced Hygienics LLC (065359009)

Establishment
Name	Address	ID/FEI	Business Operations
Wisconsin Pharmacal Company		800873986	manufacture(63002-002)