Label: INSTANT HAND SANITIZER- 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 May 5, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient                                 Purpose

    Ethyl Alcohol 62% w/w                       Antiseptic      

  • DESCRIPTION

    Uses:

    Hand sanitizer to help decrease bacteria on the skin that could cause diseases



  • WARNINGS

    Warnings:

    Flammable. Keep away from fore or flame.

    For external use only-hands.

     When using this product, do not use in or near the eyes.  In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a physician if irritation or skin rash develops.

    Keep out of reach of children

    if accidentally ingested, seek medical help or contact a Poison Control Center immediately.


  • INDICATIONS & USAGE

        Directions

    •   Place enough product in your palm to thoroughly cover your hands
    • rub hands briskly together until dry
    • children under 6 years of age should be supervised when using this product
  • STORAGE AND HANDLING

            Other Information

    • Store below 105F  
    • May discolor certain fabrics.
    • Maybe harmful to wood finishes and plastics
  • INACTIVE INGREDIENT

    Inactive Ingredients:

    carbomer, fragrance, glycerin, triethanolamine, propylene glycol, deionized water, aloe barbadensis gel

  • PRINCIPAL DISPLAY PANEL

    thbottle label

  • PRINCIPAL DISPLAY PANEL

    cardblister card

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25225-015(NDC:None)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R) 35.6 g  in 100 g
    Propylene Glycol (UNII: 6DC9Q167V3) 0.5 g  in 100 g
    Glycerin (UNII: PDC6A3C0OX) 1 g  in 100 g
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.01 g  in 100 g
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) 0.33 g  in 100 g
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) 0.01 g  in 100 g
    TROLAMINE (UNII: 9O3K93S3TK) 0.35 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25225-015-0130 g in 1 BOTTLE, PLASTIC
    2NDC:25225-015-0260 g in 1 BOTTLE, PLASTIC
    3NDC:25225-015-04237 g in 1 BOTTLE, PLASTIC
    4NDC:25225-015-05500 g in 1 BOTTLE, PLASTIC
    5NDC:25225-015-03222 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33305/05/2010
    Labeler - Unique Holding Group Inc (529047265)
    Registrant - Unique Holding Group Inc (529047265)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unique Holding Group Inc529047265manufacture
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