ADVANCED HAND SANITIZER- benzalkonium chloride liquid
Vitane Pharmaceuticals, Inc.

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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Vitane Pharmaceuticals Advanced Hand Sanitizer (Alcohol-Free)

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.

Discontinue use

if irritation or redness develops. If condition persists for more than 72 hours consult a doctor.

Keep out of reach of children.

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

Directions

Apply on hands as needed. Rub briskly together until dry.

Inactive ingredients

Ionized water, Carbamide

Storage

Store at room temperature 68 to 77F (20 to 25C) in original container.

Company Information

Distributed by:

Vitane Pharmaceuticals, Inc.

125 Wells Avenue,

Congers, New York 10920

www.vitanepharma.com

MADE IN THE U.S.A.

VITANE

Quality to Life

MADE IN USA

ADVANCED

Hand Sanitizer

Fight against 99.99% of Germs

alcohol-free triclosan-free fragrance-free

Non-Irritating / Non-Stinging

Antimicrobial

Net 3.4fl.oz/100ml

ADVANCED HAND SANITIZER
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60577-474
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
UREA (UNII: 8W8T17847W)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:60577-474-01	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/18/2020	09/20/2023
2	NDC:60577-474-02	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/18/2020	09/20/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/18/2020	09/20/2023

Labeler - Vitane Pharmaceuticals, Inc. (029029638)

Name	Address	ID/FEI	Business Operations
Establishment
Vitane Pharmaceuticals, Inc.		029029638	label(60577-474) , pack(60577-474)

Revised: 9/2023

Document Id: 2d510854-ebac-42dc-bc59-9f5541c32042

Set id: a5f30801-2b65-a4da-e053-2995a90a6894

Version: 3

Effective Time: 20230921

Vitane Pharmaceuticals, Inc.