Label: INSTANT HAND SANITIZER AND MOISTERIZER- ethyl 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 September 4, 2013

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  • ACTIVE INGREDIENT



    Active Ingredients: Ethyl Alcohol 62% w/w

  • PURPOSE



    Purpose: Antiseptic

  • 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.

  • INDICATIONS & USAGE

    Uses

    • for hand washing to decrease bacteria on the skin
    • recommended for repeated use.
  • WARNINGS



    Warnings: For external use only.

    Flammable, keep away from fire or flame.

    Do not use in eyes. In case of eye contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation and redness develops andd persists longer than 72 hours.

  • DOSAGE & ADMINISTRATION



    Directions:

    Wet hands thoroughly with product

    Briskly rub hands together until dry

    Supervise children in the use of this product

  • INACTIVE INGREDIENT



    Inactive ingredients: Water (Aqua), Fragrance, Triethanolamine, Carbomer, Titanium Dioxide, Isopropyl Myristate, Glycerin, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

  • PRINCIPAL DISPLAY PANEL

    Kills 99.9%  of germs

    Personal Care

    Instant Hand Sanitizer and Moisterizer

    All in one

    Moisturizes and Sanitizes Your Hands

    8 fl oz (236 ml)

    PC HandSanitizer Label

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER AND MOISTERIZER  
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-9086
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL146 mL  in 236 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-9086-2236 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/14/2011
    Labeler - Personal Care Products (966155082)
    Registrant - Personal Care Products (966155082)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Liyuan Daily Chemical Products Co., Ltd530766098manufacture(29500-9086)
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