Label: YOGARDTM HAND SANITIZER- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 July 27, 2020

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  • Active Ingredient

    Ethyl Alcohol 64%

    Purpose

    Antisepic

  • Use

    instant hand sanitizer
    .suitable for disinfection of sanitary hands and surgical hands
    .recommended for repeated use

  • WARNINGS

    Warnings Flammable, Keep away from fire or flame.
    For external use only
    When using this product●Keep out of eyes. lfcontact with eyes occurs,
    rinse promptly and thoroughly with water.
    Stop use and ask a doctor if significant irtation, or sensitizaion develops.
    Do notuse on chronic skin conditions such as a leg ulcer ,diaper rash,or hand eczema.

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

  • Directions

    Directions Apply to clean, dry hands. Wet hands thoroughly with product and allow to dry.

  • Inactive ingredients

    Aqua, Glycerol, Aloe Barbadensis Extract, Tocopheryl Acetate (Vitamin E), Carbomer, Triethanolamine

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    YOGARDTM HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78920-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL64 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78920-001-01120 in 1 BOX07/25/2020
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:78920-001-0220 in 1 BOX07/25/2020
    2300 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:78920-001-0324 in 1 BOX07/25/2020
    3500 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:78920-001-0410 in 1 BAG07/25/2020
    41000 mL in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:78920-001-0530 in 1 TRAY07/25/2020
    520000 mL in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:78920-001-064 in 1 TRAY07/25/2020
    6100000 mL in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:78920-001-074 in 1 TRAY07/25/2020
    7200000 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/25/2020
    Labeler - Zhejiang Meijiahua Medical Technology Co., Ltd. (553178862)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Meijiahua Medical Technology Co., Ltd.553178862manufacture(78920-001)