ZeVana Hand Sanitizer by Land View, Inc. Hand Sanitizer with Gel

ZeVana Hand Sanitizer by

Drug Labeling and Warnings

ZeVana Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Land View, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ZEVANA HAND SANITIZER- hand sanitizer with gel, zevana gel 
HAND SANITIZER WITH GEL- hand sanitizer with gel gel 
Land View, 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.

----------

Hand Sanitizer with Gel

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Glycerol (1.45% v/v).
Hydrogen peroxide (0.125% v/v).
Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Alcohol 80% v/v. Purpose: Antiseptic

Antiseptic Hand Sanitizer

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

For external use only. Flammable. Keep away from heat or flame.

• in children less than 2 months of age
• on open skin wounds

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

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical healp or contact a Poison Control Center right away.

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

glycerin, hydrogen peroxide, water, Ammonium Polyacryloyldimethyl Taurate

ZeVana Hand Sanitizer

3785.41 NDC: 79499-003-83

Hand Sanitizer w/Gel

946353ml NDC: 79499-002-83

ZEVANA HAND SANITIZER 
hand sanitizer with gel, zevana gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79499-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)	0.7 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.02 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	100 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	34 mL  in 100 mL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79499-003-83	3785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2020	05/20/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/31/2020	05/20/2021

HAND SANITIZER WITH GEL 
hand sanitizer with gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79499-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	100 mL  in 100 mL
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)	0.7 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	34 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.02 mL  in 100 mL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79499-002-83	946353 mL in 1 DRUM; Type 0: Not a Combination Product	07/24/2020	05/20/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/24/2020	05/20/2021

Labeler - Land View, Inc. (117561398)

Revised: 6/2021

Document Id: c4d3ea22-7c1b-7311-e053-2a95a90a779c

34390-5

Set id: aae2d983-78d0-4efc-e053-2995a90ab036

Version: 5

Effective Time: 20210615