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

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

Medically reviewed by . Last updated on May 7, 2020.

Dosage form: gel
Ingredients: ALCOHOL 65mL in 100mL
Labeler: Woosin Cosmetics Co., Ltd.
NDC Code: 74351-2102

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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:

  • 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.
  • Glycerol (1.45% v/v).
  • Hydrogen peroxide (0.125% v/v).
  • 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 76.448% 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

    HEMIRUS HAND SANITIZER GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74351-2102
    Route of AdministrationTOPICALDEA Schedule    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (ALCOHOL) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    D&C ORANGE NO. 4 
    PHENOXYETHANOL 
    METHYLPARABEN 
    WATER 
    TROLAMINE 
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
    ORANGE 
    ISOPROPYL MYRISTATE 
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage Description
    1NDC:74351-2102-1500 mL in 1 BOTTLE, DISPENSING
    2NDC:74351-2102-2100 mL in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/07/202005/07/2024
    Labeler - Woosin Cosmetics Co., Ltd. (688227829)
    Registrant - Woosin Cosmetics Co., Ltd. (688227829)
    Establishment
    NameAddressID/FEIOperations
    Woosin Cosmetics Co., Ltd.688227829manufacture(74351-2102)

    Document Id: a50af4e5-4a69-2869-e053-2995a90a8b73 Set id: a50af5b9-803b-144d-e053-2a95a90a2e4f Version: 1 Effective Time: 20200507  Woosin Cosmetics Co., Ltd.

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