Label: ASSURED INSTANT HAND SANITIZER- 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 September 25, 2009

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  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredients                                  Purpose

    Ethyl Alcohol 62 percent                       Antiseptic

  • PURPOSE

    Uses

    Hand sanitizer to help decrease bacteria on the skin.

    When water, soap and towel are not available.

    Recommended for repeated use.

  • WARNINGS AND PRECAUTIONS

    Warnings      For external use only.

  • SAFE HANDLING WARNING

    Flammable. Keep away from fire or flame.

  • WHEN USING

    When using this product, avoid contact with eyes.

    In case of contact flush eyes with water.

  • STOP USE

    Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Children must be supervised in use of this product.

  • DOSAGE & ADMINISTRATION

    Directions

    Pump as needed into your palms and thoroughly spread on both hands.

    Rub into skin until dry.

  • STORAGE AND HANDLING

    Other Information

    Store at 120 degrees  C      68 degrees to 77 degrees F

    May discolor fabrics.


  • INACTIVE INGREDIENT

    Inactive Ingredients

    water, triethanolamine , glycerin, propylene glycol, tocopheryl acetate,

    aloe barbadensis gel carbomer, fragrance.

  • DESCRIPTION

    This product is not manufactured or distributed by Johnson and Johnson

    or McNeil-PPC, Inc. distributor of Purell hand sanitizers.


    Distributed By: GREENBRIAR INTERNATIONAL, INC.,

    CHESAPEAKE, VA 23320

    MADE IN CHINA

  • PRINCIPAL DISPLAY PANEL

    ASSURED

    Kills 99.99 percent of Germs

    Instant Hand Sanitizer

    with Moisturizers

    Vitamin E and Aloe



    Same active ingredient as Purell Hand Sanitizer

    8 FL OZ. 237 ml

  • PRINCIPAL DISPLAY PANEL


    VitaminEAloe

  • INGREDIENTS AND APPEARANCE
    ASSURED INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-1070
    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)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-1070-1237 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33310/01/2009
    Labeler - Greenbrier International, Inc. (610322518)
    Registrant - Ningbo Pulisi Daily Chemical Products Co., Ltd. (529047265)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Pulisi Daily Chemical Products Co., Ltd.529047265manufacture
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