Hand Sanitizer by Nanz Life Science Inc. / Nanz Med Science Pharma Private Limited Alcorub Sanitizer

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]

GERMASAVE- hand sanitizer gel gel 
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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Alcorub Sanitizer

1. Alcohol (ethanol)- USP (66.5%, volume/volume (v/v))
2. Sterile distilled water or boiled cold water.

Active Ingredient(s)

Alcohol 66.5% 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

Isopropyl alcohol 3.5%v/v, Carbomer 941, Glyceryl acrylated/acrylic acid copolymer, Lime Oil, PEG-40 Hydrogenated Castor Oil, Aloe Vera Juice, Triethanolamine, Purified Water

Package Label - Principal Display Panel

Example of Plastic Bottle

20ML NDC: 80129-500-01

50ML NDC: 80129-500-02

60ML NDC: 80129-500-03

100ML NDC: 80129-500-04

250ML NDC: 80129-500-05

500ML NDC: 80129-500-06

1000ML NDC: 80129-500-07

2000ML NDC: 80129-500-08

3785ML NDC: 80129-500-09

5000ML NDC: 80129-500-10

GERMASAVE 
hand sanitizer gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80129-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	66.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)	0.3 g  in 100 mL
LIME OIL (UNII: UZH29XGA8G)	0.3 g  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	0.6 g  in 100 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302)	3.5 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.75 g  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.55 g  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.5 g  in 100 mL
WATER (UNII: 059QF0KO0R)	100 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80129-500-01	20 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/24/2020
2	NDC: 80129-500-02	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/24/2020
3	NDC: 80129-500-03	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/24/2020
4	NDC: 80129-500-04	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/24/2020
5	NDC: 80129-500-05	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/24/2020
6	NDC: 80129-500-06	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/24/2020
7	NDC: 80129-500-07	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/24/2020
8	NDC: 80129-500-08	2000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/24/2020
9	NDC: 80129-500-09	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/24/2020
10	NDC: 80129-500-10	5000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/24/2020	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(80129-500)

Revised: 3/2023

Document Id: f75a998c-0e7b-076a-e053-6294a90a20e7

34390-5

Set id: ada2d48e-ed87-04b8-e053-2a95a90a48e9

Version: 17

Effective Time: 20230320