Hemirus Hand Sanitizer Gel 70% by Woosin Cosmetics Co., Ltd. Hand Sanitizer

Hemirus Hand Sanitizer Gel 70% by

Drug Labeling and Warnings

Hemirus Hand Sanitizer Gel 70% by is a Otc medication manufactured, distributed, or labeled by Woosin Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEMIRUS HAND SANITIZER GEL 70%- alcohol gel 
Woosin Cosmetics Co., Ltd.

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

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 82.404% 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

Package Label - Principal Display Panel

500ml bottle: NDC: <a href=/NDC/74351-2002-1>74351-2002-1</a>300ml bottle: NDC: <a href=/NDC/74351-2002-2>74351-2002-2</a>100ml bottle: NDC: <a href=/NDC/74351-2002-3>74351-2002-3</a>50ml tube : NDC: <a href=/NDC/74361-2002-4>74361-2002-4</a>30ml tube: NDC: <a href=/NDC/74351-2002-5>74351-2002-5</a>

HEMIRUS HAND SANITIZER GEL 70% 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 74351-2002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL82.404 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
AMINOMETHYLPROPANOL (PERFLUORO-C6-C12 ETHYL)PHOSPHATE (UNII: QCD5R22RNT)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
ORANGE (UNII: 5EVU04N5QU)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 74351-2002-1500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/06/2020
2NDC: 74351-2002-2300 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/06/2020
3NDC: 74351-2002-3100 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/06/2020
4NDC: 74351-2002-450 mL in 1 TUBE; Type 0: Not a Combination Product04/06/2020
5NDC: 74351-2002-530 mL in 1 TUBE; Type 0: Not a Combination Product04/06/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/02/202004/16/2020
Labeler - Woosin Cosmetics Co., Ltd. (688227829)
Registrant - Woosin Cosmetics Co., Ltd. (688227829)
Establishment
NameAddressID/FEIBusiness Operations
Woosin Cosmetics Co., Ltd.688227829manufacture(74351-2002)

Revised: 4/2020
Document Id: a375fcae-3bfc-65fd-e053-2a95a90a187e
Set id: a2463757-9e8c-371e-e053-2995a90acb6f
Version: 5
Effective Time: 20200417
 
Woosin Cosmetics Co., Ltd.