Germasave Liquid 80% v/v Ethanol

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Nanz Life Science Inc., Nanz Med Science Pharma Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- hand sanitizer liquid 
Nanz Life Science Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Germasave Liquid 80% v/v Ethanol

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.

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

Warnings

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

Do not use

• 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 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.

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.

Directions

• 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.

Other information

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

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP, diisopropyl adipate, lime oil (fragrance), octyldodecanol, myristyl alcohol, gluconolactone

Package Label - Principal Display Panel

Sample of plastice bottle.

No french translation

No label of WHO formulation

20 mL NDC: 80129-003-01

50ml NDC: 80129-003-02

60ml NDC: 80129-003-03

100ml NDC: 80129-003-04

250ml NDC: 80129-003-05

500ml NDC: 80129-003-06

1000ml NDC: 80129-003-07

2000ml NDC: 80129-003-08

3785ml NDC: 80129-003-09

5000ml NDC: 80129- 003-10

HAND SANITIZER 
hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80129-003
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
LIME OIL (UNII: UZH29XGA8G)	0.1 g  in 100 mL
OCTYLDODECANOL (UNII: 461N1O614Y)	0.2 g  in 100 mL
MYRISTYL ALCOHOL (UNII: V42034O9PU)	0.2 g  in 100 mL
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)	1 g  in 100 mL
WATER (UNII: 059QF0KO0R)	100 mL  in 100 mL
GLUCONOLACTONE (UNII: WQ29KQ9POT)	0.1 g  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80129-003-01	20 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/18/2020
2	NDC: 80129-003-02	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/18/2020
3	NDC: 80129-003-03	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/18/2020
4	NDC: 80129-003-04	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/18/2020
5	NDC: 80129-003-05	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/18/2020
6	NDC: 80129-003-06	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/18/2020
7	NDC: 80129-003-07	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/18/2020
8	NDC: 80129-003-08	2000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/18/2020
9	NDC: 80129-003-09	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/18/2020
10	NDC: 80129-003-10	5000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/18/2020	03/12/2023

Labeler - Nanz Life Science Inc. (204168423)

Registrant - Nanz Life Science Inc. (204168423)

Establishment
Name	Address	ID/FEI	Business Operations
Nanz Med Science Pharma Private Limited		864425735	manufacture(80129-003)

Revised: 3/2023

Document Id: f75b0bc3-e04e-a8e5-e053-6294a90a6d8e

34390-5

Set id: ad2cfc71-e5ea-c448-e053-2a95a90a12a6

Version: 15

Effective Time: 20230320