Label: HAND SANITIZER GEL- 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 July 15, 2018

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  • ACTIVE INGREDIENT

    Active Ingredient:
    Ethyl Alcohol 62%

  • PURPOSE

    Purpose:
    Antimicrobial

  • WARNINGS

    WARNING:
    FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.     FOR EXTERNAL USE ONLY.DO NOT USE IN THE EYES.

  • STOP USE

    DISCONTINUE USE IF IRRITATION AND REDNESS DEVELOP.
    IF CONDITION PERSISTS FOR MORE THAN 72 HOURS, CONSULT A DOCTOR OR PHYSICIAN.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • DOSAGE & ADMINISTRATION

    Directions:
    Rub into hands until dry.

  • INACTIVE INGREDIENT

    Water, Aloe barbadenis Leaf Juice, Glycerin,Propylene Glycol, Olive Oil, Fragrance, Carbomer, Triethanolamine, FD&C Blue No.1, FD&C Yellow No.5.

  • STORAGE AND HANDLING

    Other Information:
    Store below 110 F.

  • INDICATIONS & USAGE

    KILLS MORE THAN 99.99% OF COMMON GERMS

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER GEL 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53603-1053
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53603-1053-129.5 mL in 1 BOTTLE; Type 0: Not a Combination Product07/14/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/14/2018
    Labeler - BB17, LLC (828378294)
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