Hand Sanitizer Wipes by VIARDEN LAB, LLC Hand sanitizer wipes

Hand Sanitizer Wipes by

Drug Labeling and Warnings

Hand Sanitizer Wipes by is a Otc medication manufactured, distributed, or labeled by VIARDEN LAB, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER WIPES- benzalkonium chloride wipes cloth 
VIARDEN LAB, 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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Hand sanitizer wipes

Active Ingredient(s)

Benzalkonium Chloride 0.13% v/v. Purpose: Antiseptic

Purpose

Antiseptic.

Use

To decrease bacteria on the skin.

Warnings

For external use only.

When using this product

• Do not use in or near the eyes.
• In case of contact, rinse eyes thoroughly with water.
• Avoid contact with open skin wounds.
• Do not use on children under 2 months of age.

Stop use and ask a doctor

if irritation or rash occurs.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Adults and children 6 years and older - Rub wipe thoroughly over all surfaces of hands and allow to dry.
• Children under 6 years - Use only under adult supervision.

Other information

• To dispose: Place in wastebasket after use.
• Do not flush.

Inactive ingredients

Propylene glycol, water.

Package Label - Canister 160 Wipes

​Canister 160 NDC: 81935-001-01

HAND SANITIZER WIPES 
benzalkonium chloride wipes cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81935-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81935-001-01	160 g in 1 CANISTER; Type 0: Not a Combination Product	05/26/2021	03/17/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/26/2021	03/17/2023

Labeler - VIARDEN LAB, LLC (117803893)

Establishment
Name	Address	ID/FEI	Business Operations
VIARDEN LAB, LLC		117803893	manufacture(81935-001)

Revised: 4/2023

Document Id: fa691225-97cb-1db3-e053-6294a90a2391

34390-5

Set id: c2ed58fc-6ab4-3dcf-e053-2995a90a57a7

Version: 2

Effective Time: 20230428