Label: GERM OUT HAND SANITIZER- ethyl alcohol 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 June 9, 2020

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Ethyl Alcohol 70% v/v.

    Purpose: Antiseptic

  • Purpose

    Antiseptic

  • Use

    hand sanitizer to help reduce bacteria on the skin

  • Safety Instructions

    Flammable, Keep away from fire and flame

  • When usinng this product

    do not  use in or near eyes. In case of contact, rinse eyes thoroghly with water.

  • Stop using 

    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 (aqua), Isopropyl Alcohol, Glycerin, Carbomer, Aminomethyl Propanol, Fragrance, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice (Aloe Vera), Fragrance, Glycerin, Tocopheryl Acetate (Vitamin E)

  • Directions

    • apply palmful to hands.
    • rub hands together vigorously until dry.
    • supervise children in the use of this product.
  • PRINCIPAL DISPLAY PANEL

    germout2

  • INGREDIENTS AND APPEARANCE
    GERM OUT HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72308-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72308-007-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product06/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/09/2020
    Labeler - Flex Beauty Labs (080858917)