BYOTROL HAND SANITIZER  - benzalkonium chloride liquid 
Advanced Hygienics 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.

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

Questions? 1-866-443-4509

byotrol

ANTIBACTERIAL FOAMING

HAND SANITIZER

ALCOHOL FREE  KILLS GERMS

POWERFUL

LONG LASTING

GENTLE

Net Contents: 16.9 FL OZ (500mL)

container label

BYOTROL HAND SANITIZER  
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63002-002
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:63002-002-9950 mL in 1 BOTTLE; Type 0: Not a Combination Product05/02/2014
2NDC:63002-002-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/25/2014
3NDC:63002-002-121250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/25/2014
4NDC:63002-002-759463 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/02/2014
Labeler - Advanced Hygienics LLC (065359009)
Establishment
NameAddressID/FEIBusiness Operations
Wisconsin Pharmacal Company800873986manufacture(63002-002)

Revised: 12/2017
Document Id: ef6a1c09-8491-4a08-bedc-a67ce00d9e23
Set id: 09edbc17-c443-4b0d-9c28-c4b8233c4d1a
Version: 6
Effective Time: 20171214
 
Advanced Hygienics LLC