Label: ASSURED INSTANT HAND SANITIZER WITH MOISTURIZERS VITAMIN E AND ALOE- 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, 2015

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  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredients

    Ethyl Alcohol 62%

  • PURPOSE

    Purpose
    Antiseptic

  • INDICATIONS & USAGE

    Uses

    • Hand sanitizer to help decrease bacteria on the skin.
    • When water, soap and towel are not available.
    • Recommended for repeated use.
  • WARNINGS

    Warnings      For external use only.

  • SAFE HANDLING WARNING

    Flammable. Keep away from fire or flame.

  • WHEN USING

    Do not apply around eyes. Do not use in ears and mouth

    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

    • wet hands thoroughly with product
    • briskly rub hands together until dry.
  • STORAGE AND HANDLING

    Other Information

    store at 20 degrees C (68 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

    Instant Hand Sanitizer

    with Moisturizers

    Vitamin E and Aloe


    Kills 99.99 percent of Germs

    Same active ingredient as Purell Hand Sanitizer

    1.8 fl oz (53.3 ml)

  • PRINCIPAL DISPLAY PANEL


    Assured1
    Assured2
  • INGREDIENTS AND APPEARANCE
    ASSURED INSTANT HAND SANITIZER WITH MOISTURIZERS VITAMIN E AND ALOE  
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-1071
    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:33992-1071-153.3 mL in 1 BOTTLE
    2NDC:33992-1071-2296 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/18/2011
    Labeler - Greenbrier International, Inc. (610322518)
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