VIROCLEAR- benzalkonium chloride liquid 
Bioinnovate Pty Ltd

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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Active Ingredient

Benzalkonium Chloride 0.12% w/w.

Purpose

Antiseptic, Hand Sanitizer

Uses

Warnings

For external use only.

When using this product

When using this product, keep out of eyes, ears and mouth. In case ofcontact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

Discontinue use if irritation and redness develops.

Keep out of reach of children

In case of accidental ingestion, seek medical attention or contact a poison control centre immediately.

Directions

Apply 2-3 sprays onto dry hands and rub hands together vigorously.

Other information

Store in a cool dry place below 104º F.

Inactive Ingredients

Water/Aqua, Leptospermum Petersonii (Lemon Bush) Leaf Extract, Matricaria Chamomilla (Chamomile) Flower Extract.

Questions or comments

Call +1 905 542 2900

Package Label - Principal Display Panel

50 mL; NDC 81909-0001-1

ViroClear 50ml Label

VIROCLEAR 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81909-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.12 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
LEPTOSPERMUM PETERSONII LEAF OIL (UNII: N37UWG52T3)  
CHAMOMILE (UNII: FGL3685T2X)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81909-0001-150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/07/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/07/2021
Labeler - Bioinnovate Pty Ltd (747092416)

Revised: 6/2021
Document Id: c42cd186-6b91-3e3a-e053-2a95a90a651c
Set id: c42cd186-6b90-3e3a-e053-2a95a90a651c
Version: 1
Effective Time: 20210607
 
Bioinnovate Pty Ltd