Label: LUXE AND WILLOW HAND SANITIZER- alcohol gel

  • NDC Code(s): 78713-002-08
  • Packager: MiWorld Accessories 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 July 17, 2020

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

  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 75%

    Purpose

    Antiseptic

  • Uses

    • To decrease bacteria on skin without soap or water
    • Recommended for repeated use
  • Warnings

    For external use only. Only on hands.

    Flammable, keep away from fire or flame.

    Do not use

    in or near eyes. In case of contact, rinse thoroughly with water

    Stop use and ask a doctor 

    if irritation and redness develop and persists for more than 72 hours

    Keep out of reach of children.

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

  • Directions

    • Put enough product on palm and rub hands until dry
    • Children under 6 years of age should be supervised while using this product
  • Inactive ingredients

    Aqua, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tetrahydroxypropyl Ethylenediamine, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    LUXE AND WILLOW HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78713-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    EDETOL (UNII: Q4R969U9FR)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78713-002-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/01/2020
    Labeler - MiWorld Accessories LLC (078708128)