Label: INSTANT 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 June 4, 2018

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  • ACTIVE INGREDIENT

    Active Ingredients:
    Ethyl Alcohol 62%

  • PURPOSE

    Purpose

    Antiseptic

  • WARNINGS

    Warning
    For External Use Only.
    Flammable, Keep away from fire or flame.

  • STOP USE

    Stop use and ask a doctor if
    significant irritation or sensitization occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    DIRECTIONS:
    Apply a liberal amount to hands and rub hands thoroughly until dry. Do not rinse or wipe off gel.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:
    Deionized water, Aloe barbadenis, Leaf Juice, Glycerin,
    Propylene glycol, Carbomer, Aminomethyl Propanol, Fragrance

  • ASK DOCTOR

    Ask a doctor before use if you have
    Deep wounds, animal bites or serious burns.

  • INDICATIONS & USAGE

    Uses

    To help reduce bacteria on the hands that can potentially cause disease.

  • WHEN USING

    When using this product
    Avoid contact with eyes, if this occurs rinse thoroughly with water and contact a physician.

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53152-2003
    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)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53152-2003-1237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/01/2018
    Labeler - AOSS Medical Supply, Inc. (787524651)
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