Label: HAND SANITIZER WITH ALOE AND VITAMIN E- 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 16, 2020

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  • Antibacterial Hand Sanitizer

  • ​Active Ingredient

    Ethyl Alcohol 71% (V/V)

  • Purpose​

    Antiseptic

  • Features:

    To decrease bacteria on the skin. Recommended for repeated use. Delicate and fast dry. Use anywhere without water.

  • Inactive Ingredients:

    Water (Aqua), Isopropyl Alcohol, Glycerin, Aloe Yohyju Matsu Ekisu, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Fragrance (Parfum).

  • Directions:

    • Place enough product in your palm to thoroughly cover your hands.
    • Rub hands together briskly until dry.
    • Children under 8 years of age should be supervised when using this product.
  • Warning:

    • 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 using and ask a doctor, if irritation or rash appears and lasts.

    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • Other information:

    • Do not store above 110°F (43°C).
    • May discolor certain fabrics or surfaces.
  • SPL UNCLASSIFIED SECTION

    Kills 99.99% of Germs

    Distributor: Tops Healthcare Product Inc.

    2233 E 49th Street, Vernon 90058 CA, USA     THP

    E-mail: customerservice@topshealthcare.com

    Production Date: Please find on the package

    Shelf life: 2 years

    Executive Standard: GB 26373

    Made in China

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER WITH ALOE AND VITAMIN E 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75227-151
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL71 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75227-151-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/26/2020
    2NDC:75227-151-03300 mL in 1 BOTTLE; Type 0: Not a Combination Product03/26/2020
    3NDC:75227-151-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/26/2020
    4NDC:75227-151-101000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/26/2020
    Labeler - Top's Healthcare Product Inc (117482389)
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