Label: HAND SANITIZER- ethyl alcohol gel

  • NDC Code(s): 71063-001-03
  • Packager: Aiyaya Cloud-Commerce Tech Co., Ltd
  • 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 November 1, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient
    Ethyl Alcohol 62%

  • PURPOSE

    Purpose
    Antiseptic

  • WARNINGS

    Warnings

    For external use only.

    Keep out of eyes. In case of contact with eyes, flush thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or redness develops. If swallowed, get medical help or contact a doctor right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep it out of children.

  • DOSAGE & ADMINISTRATION

    Directions:

    Pump as needed into your palms to cover hands. Rub hands together briskly until dry.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Aloe Barbadenis Leaf Juice, Glycerin, Propylene Glycol, Fragrance, FD&C Red No.4, FD&C Yellow No. 5

  • INDICATIONS & USAGE

    Uses

    Decrease bacteria on hands

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71063-001
    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
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71063-001-0329 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/01/2016
    Labeler - Aiyaya Cloud-Commerce Tech Co., Ltd (529721734)
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