Label: U INSTANT HAND SANITIZER CLASSIC 2OZ- ethyl alcohol gel

  • NDC Code(s): 52000-201-01
  • Packager: Universal Distribution Center LLC
  • 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 1, 2020

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  • Drug Facts Active Ingredient

    Ethyl Alcohol 62.0 percent

  • Purpose

    Antimicrobial

  • Uses

    Hand Sanitizer to help reduce bacteria on skin.

  • WARNINGS

    Flammable. Keep away from fire or flame.

    For external use only.

  • When using this product,

    do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask doctor if irritation or rash appears and lasts.

  • Keep out of reach for children.

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

  • Directions

    • Place enough Product in your palm to thoroughly spread on both hands and rub into the skin until dry.
    • Children under 6 years of age should be supervised when using this product.
  • Other Information:

    • Store below 106 Fahrenheit (41 Degree Celsius)
    • May discolor certain fabrics or surfaces.
  • INACTIVE INGREDIENTS:

    Water (Aqua), Aloe Barbadensis Leaf Juice, Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate (Vitamin E), triethanolamine.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    U INSTANT HAND SANITIZER CLASSIC 2OZ 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER 934 (UNII: Z135WT9208)  
    TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-201-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/01/2020
    Labeler - Universal Distribution Center LLC (019180459)
    Registrant - Universal Distribution Center LLC (019180459)
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