Label: ASSURED INSTANT HAND SANITIZER WITH MOISTURIZERS ALOE VERA AND MOISTURIZERS- 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 May 9, 2012

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  • ASSURED Instant Hand Sanitizer WITH MOISTURIZERS Aloe Vera and Moisturizers

              
  • Active Ingredient

    Ethyl Alcohol 62.0%           
  • Purpose

    Antimicrobial
  • Uses

    • for handwashing to decrease bacteria on the skin
    • recommended for repeated use
  • Warnings

    For external use only.

    Flammable, keep away from heat and flame.


  • Do not use

    in the eyes. In case of contact, rinse eyes thoroughly with water.
  • Stop use and ask a doctor if

    irritation and redness develop and persist for more than 72 hours.

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • wet hands thoroughly with product
    • briskly rub hand until dry
    • supervise children under 6 years in the use of this product
  • Other Information

    • store at 20 degrees C to 25 degrees C (68 degrees to 77 degrees F)
    • may discolor certain fabrics


  • Inactive Ingredients

    water, carbomer, triethanolamine , glycerin, propylene glycol,  fragrance, aloe barbadensis leaf juice,  fd and c blue no.,1, fd and c yellow no. 5

  • SPL UNCLASSIFIED SECTION

    This product is not manufactured or distributed by Gojo Industruies Inc, distributor of the registered trademark Purell



    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

    Aloe Vera and Moisturizers



    Same active ingredient as Purell Hand Sanitizer


  • ASSURED Instant Hand Sanitizer WITH MOISTURIZERS Aloe Vera and Moisturizers 10oz/295ml (33992-1061-0) | ASSURED Instant Hand Sanitizer WITH MOISTURIZERS Aloe Vera and Moisturizers 8oz/237ml (33992-1061-1)

    AloeVera8oz

    AloeVera10oz

  • INGREDIENTS AND APPEARANCE
    ASSURED INSTANT HAND SANITIZER WITH MOISTURIZERS ALOE VERA AND MOISTURIZERS 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-1061
    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)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-1061-0295 mL in 1 BOTTLE
    2NDC:33992-1061-1237 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/27/2011
    Labeler - Greenbrier International, Inc. (610322518)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Unichem Household Products Co., Ltd.528196956manufacture
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