HAND SANITIZER 72% ETHYL ALCOHOL- hand sanitizer 72% ethyl alcohol liquid 
NZ Enterprises 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

Purpose

Antiseptic, Hand Sanitizer

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:

  1. 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.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. 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.

Do not use

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

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

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Use

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

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

Warnings

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

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

Directions

Package label principal display panel

HAND SANITIZER 72% ETHYL ALCOHOL 
hand sanitizer 72% ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74311-175
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 0.26425 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.145 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.0125 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorMANGOImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74311-175-088 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/15/2020
Labeler - NZ Enterprises LLC (084052289)
Registrant - NZ Enterprises LLC (084052289)
Establishment
NameAddressID/FEIBusiness Operations
NZ Enterprises LLC084052289manufacture(74311-175)

Revised: 4/2020
Document Id: a334fde9-3b74-0a47-e053-2a95a90a3228
Set id: a334fde9-3b82-0a47-e053-2a95a90a3228
Version: 1
Effective Time: 20200415
 
NZ Enterprises LLC