Germasave Liquid 80% v/v Ethanol

Germasave by

Drug Labeling and Warnings

Germasave 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]

GERMASAVE- hand sanitizer liquid 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

For all package size

Sample of plastice bottle.

No french translation

No label of WHO formulation

20 mL NDC: 80129-300-01

50ml NDC: 80129-300-02

60ml NDC: 80129-300-03

100ml NDC: 80129-300-04

250ml NDC: 80129-300-05

500ml NDC: 80129-300-06

1000ml NDC: 80129-300-07

2000ml NDC: 80129-300-08

3785ml NDC: 80129-300-09

5000ml NDC: 80129- 003-10

GERMASAVE 
hand sanitizer liquid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80129-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
GLUCONOLACTONE (UNII: WQ29KQ9POT) 0.1 g  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80129-300-0120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/18/2020
2NDC: 80129-300-0250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/18/2020
3NDC: 80129-300-0360 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/18/2020
4NDC: 80129-300-04100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/18/2020
5NDC: 80129-300-05250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/18/2020
6NDC: 80129-300-06500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/18/2020
7NDC: 80129-300-071000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/18/2020
8NDC: 80129-300-082000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/18/2020
9NDC: 80129-300-093785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/18/2020
10NDC: 80129-300-105000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/18/202003/12/2023
Labeler - Nanz Life Science Inc. (204168423)
Registrant - Nanz Life Science Inc. (204168423)
Establishment
NameAddressID/FEIBusiness Operations
Nanz Med Science Pharma Private Limited864425735manufacture(80129-300)

Revised: 3/2023
Document Id: f75a0002-ad08-83ac-e053-6294a90a7032
Set id: ae597e93-08bd-327e-e053-2a95a90a0ac3
Version: 14
Effective Time: 20230320
 
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