Label: GERMS BE GONE HAND SANITIZER- ethyl alcohol gel

  • NDC Code(s): 50157-503-01, 50157-503-02, 50157-503-03, 50157-503-04, view more
    50157-503-05
  • Packager: Brands International
  • 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 16, 2020

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  • Active Ingredients

    Ethyl Alcohol 80% w/w

    Purpose: Antiseptic

  • Purpose

    Antiseptic

  • Safety Instructions

    Flammable, Keep away from fire and flame

  • Ask Doctor

    Stop Use and Ask a doctor if irritation or redness develops

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact Poison Control right away

  • Other Information

    Store below 110°F (43°C)
    May discolor certain fabrics or surfaces.

  • Inactive Ingredients

    water, isopropyl alcohol, glycerin, carbomer, aminomethyl propanol, fragrance, propylene glycol, Aloe, Tocopheryl Acetate. isopropyl myristate

  • Directions

    • Place enough product in your palm to thoroughly cover your hands
    • Rub hands together briskly until dry
    • Children under 6 years of age should be supervised when using this product.
  • Warnings

    For external use only.

    Flammable. Keep away from fire or flame.

  • Uses

    • helps reduce bacteria on the skin that could cause disease
    • Recommended for repeated use
  • PRINCIPAL DISPLAY PANEL

    NDC:

    50157-503-01: 118ml

    50157-503-02: 148ml

    50157-503-05: 148ml : Bottle, Spray

    50157-503-03: 236ml

    50157-503-04: 443ml

    IMG_1688

    14oz

    4oz

    5oz

    8oz

  • INGREDIENTS AND APPEARANCE
    GERMS BE GONE HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-503
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-503-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product03/02/2020
    2NDC:50157-503-02148 mL in 1 BOTTLE; Type 0: Not a Combination Product03/02/2020
    3NDC:50157-503-03236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/02/2020
    4NDC:50157-503-04443 mL in 1 BOTTLE; Type 0: Not a Combination Product03/02/2020
    5NDC:50157-503-05148 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/02/2020
    Labeler - Brands International (243748238)
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