Label: HAND SANITIZER WITH ALOE VERA- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 17, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient
    Ethyl Alcohol 62%

  • PURPOSE

    Purpose

    Antiseptic

  • WARNINGS

    Warning

    For external use only

    Flammable

    Keep away from fire or flame

  • 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

    Squeeze on hands and rub hands together until dry

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol, Carbomer, Aminomethyl Propanol, Fragrance

  • INDICATIONS & USAGE

    Use

    Decreases bacteria on the hands

  • OTHER SAFETY INFORMATION

    Keep out of eyes

    In case of eye contact immediately flush with water and get medical help

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER WITH ALOE VERA 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69556-001
    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 INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69556-001-01236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/17/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/17/2016
    Labeler - Kentron Healthcare, Inc. (618825723)
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