Label: LUXURY 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 September 17, 2020

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  • Active Ingredients

    Ethyl Alcohol 75%

    Purpose: Antiseptic

  • Purpose

    Antiseptic

  • Uses

    • helps reduce bacteria on the skin that could cause disease
    • Recommended for repeated use
  • 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.

  • 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, glycerin, carbomer, aminomethyl propanol, fragrance, Aloe, Tocopheryl Acetate. Please review Label for further details

  • PRINCIPAL DISPLAY PANEL

    1

    lh2

    lh1

  • INGREDIENTS AND APPEARANCE
    LUXURY HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76772-017
    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)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    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:76772-017-47472 mL in 1 BOTTLE; Type 0: Not a Combination Product03/02/2020
    2NDC:76772-017-0660 mL in 1 BOTTLE; Type 0: Not a Combination Product03/02/2020
    3NDC:76772-017-23236 mL in 1 BOTTLE; 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 - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)
    Registrant - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)
    Establishment
    NameAddressID/FEIBusiness Operations
    TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI533120570manufacture(76772-017)
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