Label: CHINESE MUGWORT ANTIBACTERIAL SPRAYS OF YISHIYUAN- hand sanitizer liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated April 24, 2020

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  • Active Ingredient(s)

    Alcohol 75% v/v. Purpose: Antiseptic.

    Kill staphylococcus aureus, escherichia coli, pseudomonas aeruginosa, and candida albicans (ATCC10231).

  • 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.

    Suitable for daily hand and skin disinfection.

  • Warnings

    1. External use only.

    2. Flammable, away from fire source.

    3. Keep out of reach of children.

  • Do not use

    • on children less than 2 months of age
    • on open skin wounds
    • in the eyes. in case of contact, rinse eyes thoroughly with water
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth.

    In case of contact with eyes, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Spray on your hands or skin when needed.

  • Other information

    Store in a cool, dry place.

  • Inactive ingredients

    Water, Essential Oil of Chinese Mugwort, Benzyldodecyldimethylammonium Bromide.

  • Package Label - Principal Display Panel

    100

  • INGREDIENTS AND APPEARANCE
    CHINESE MUGWORT ANTIBACTERIAL SPRAYS OF YISHIYUAN 
    hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75507-1011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ARTEMISIA ARGYI LEAF (UNII: 2JYC99Q0WZ)  
    BENZODODECINIUM BROMIDE (UNII: IRY12B2TQ6)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75507-1011-6100 in 1 BOX04/24/2020
    1NDC:75507-1011-1100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/24/2020
    Labeler - Hubei Yishiyuan Chinese Mugwort Biotechnology Co., Ltd. (540872992)
    Registrant - A03 Lab of BTS (548009541)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hubei Yishiyuan Chinese Mugwort Biotechnology Co., Ltd.540872992label(75507-1011) , manufacture(75507-1011)
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