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EXIHUAN Hand Sanitizer by Yunnan Thousand Sheng Pharmaceutical Group Co. Ltd.

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EXIHUAN Hand Sanitizer by Yunnan Thousand Sheng Pharmaceutical Group Co. Ltd.

Medically reviewed by . Last updated on Apr 6, 2020.

Dosage form: liquid
Ingredients: ALCOHOL 22.5mL in 30mL
Labeler: Yunnan Thousand Sheng Pharmaceutical Group Co. Ltd.
NDC Code: 74431-201

Further information

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

EXIHUAN 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) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Sodium hyaluronate
  • Butanediol
  • Triethanolamine
  • collagen
  • Carbomer
  • 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 75% 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

    Sodium hyaluronate, Butanediol, Triethanolamine, collagen, Carbomer, purified water USP

    Package Label - Principal Display Panel

    30 mL NDC: 74431-201-01

    EXIHUAN HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74431-201
    Route of AdministrationTOPICALDEA Schedule    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (ALCOHOL) ALCOHOL22.5 mL  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER 
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE 
    WATER 
    BUTANEDIOL (MIXED ISOMERS) 
    TROLAMINE 
    COLLAGENASE CLOSTRIDIUM HISTOLYTICUM 
    Packaging
    #Item CodePackage Description
    1NDC:74431-201-0130 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Yunnan Thousand Sheng Pharmaceutical Group Co. Ltd. (554528835)
    Establishment
    NameAddressID/FEIOperations
    Yunnan Thousand Sheng Pharmaceutical Group Co. Ltd.554528835manufacture(74431-201)

    Document Id: a2a13647-8585-1ac6-e053-2a95a90aae45 Set id: a2a13647-8593-1ac6-e053-2a95a90aae45 Version: 1 Effective Time: 20200406  Yunnan Thousand Sheng Pharmaceutical Group Co. Ltd.

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