Label: GERM FREE DISINFECTANT GEL- hand sanitizer gel

  • 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 May 21, 2020

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  • Active Ingredient

    Ethanol 70% (v/v)

  • Purpose

    Antibacterial sterilization

  • 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 of 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 asrtious condition.

    Keep out of reach of children.

    If swallowed, get medical help or contact a poison Control Center right away.

  • Directions

    Take appropriate amount of this product, rub with both hands until dry, no need to wash by hand.

  • Other information

    Store between 15-30C (59-86F)

    Avoid freexing and excessive heat above 40C(104F)

  • Inactive ingredients

    water, propanediol, carbomer, triethanolamine, chlorphenesin, aloe barbadensis leaf extract.

  • Questions?

    +83 20 36632232

  • Package Label - Principal Display Panel

    77311-016

  • INGREDIENTS AND APPEARANCE
    GERM FREE DISINFECTANT GEL 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77311-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77311-016-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/10/2020
    Labeler - Guangzhou Mengfeishi Pharmaceutical Technology Co., Ltd. (402685342)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Mengfeishi Pharmaceutical Technology Co., Ltd.402685342manufacture(77311-016)
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