Label: HAND SANITIZER WITH ALOE- 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 February 18, 2017

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  • ACTIVE INGREDIENT

    Active Ingredient:
    Ethyl Alcohol 63% VOL

  • PURPOSE

    Purpose

    Antiseptic

  • WARNINGS

    Warnings

    For external use only.

    Flammable. Keep away from heat and flame.

  • STOP USE

    If irritation occurs, stop use and ask a doctor.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    Directions:

    Place enough product in your palm to completely cover your hands. Rub hands together and allow to dry without wiping.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Fragrance, Glycerin, Maltodextrin, Propylene Glycol, Water

  • STORAGE AND HANDLING

    Other Information

    Store at 5C to 40C (41F to 104F). May discolor some fabrics.

  • INDICATIONS & USAGE

    Uses

    Hand sanitizer to help reduce bacteria on the skin. Recommended for repeated use.

  • WHEN USING

    When using this product

    Avoid contact with eyes. In case of eye contact, immediately and thoroughly rinse eyes with water.

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER WITH ALOE 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70424-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL63 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70424-002-0129 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/22/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/22/2016
    Labeler - Evergreen Research and Marketing, LLC (133091806)
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