Label: ANTIBACTERIAL HAND SANITIZER- ethyl alcohol liquid

  • 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 April 28, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • Uses 

    • To help reduce bacteria on the skin.

  • Warnings

    For external use only. •Flammable. Keep away from fire or flame.


    When using this product • avoid contact with eyes. If contact occurs, rinse with water.


    Stop use and ask a doctor if skin irritation or redness develops.

    Keep out of reach of children. • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • Directions

    • put enough product in your palm to cover hands and rub hands together until dry. • for children under 6, use only under adult supervision.

    • not recommended for infants.

  • Other information:

    • store at a temperature below 110°F.(43°C).
    • may discolor some fabrics.
  • Inactive ingredients​:

    Water (Aqua), Glycerin, Propylene Glycol, Carbomer, Fragrance, Triethanolamine,  Aloe Barbadensis Leaf Extract, Tocopheryl Acetate (Vitamin E),  FD&C Yellow No.5 (Tartrazine), FD&C Blue No.1.

  • SPL UNCLASSIFIED SECTION

    KILLS GERMS WITHOUT WATER

    Effective at eliminating over 99.99% of many common harmful germs and bacteria.

    Distributed by:Royal Deluxe Accessories,LLC

    Made in China / Fabrique'en Chine / Hecho en China

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZER 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77043-166
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77043-166-02236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/30/2020
    2NDC:77043-166-01500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/30/2020
    Labeler - Royal Deluxe Accessories Llc (831333054)
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