Label: ASSURED INSTANT HAND SANITIZER WITH MOISTURIZERS ALOE VERA AND MOISTURIZERS - alcohol gel

  • NDC Code(s): 33992-1061-0, 33992-1061-1
  • Packager: Greenbrier International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 05/12

If you are a consumer or patient please visit this version.

  • ASSURED Instant Hand Sanitizer WITH MOISTURIZERS Aloe Vera and Moisturizers

              
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  • Active Ingredient

    Ethyl Alcohol 62.0%           
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  • Purpose

    Antimicrobial
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  • Uses

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

    For external use only.

    Flammable, keep away from heat and flame.


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  • Do not use

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

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

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  • Keep out of reach of children

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

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  • Directions

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

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


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  • 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

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  • 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

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  • 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


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  • 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)
  • INGREDIENTS AND APPEARANCE
    ASSURED INSTANT HAND SANITIZER WITH MOISTURIZERS ALOE VERA AND MOISTURIZERS 
    alcohol gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-1061
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:33992-1061-0 295 mL in 1 BOTTLE
    2 NDC:33992-1061-1 237 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 06/27/2011
    Labeler - Greenbrier International, Inc. (610322518)
    Establishment
    Name Address ID/FEI Business Operations
    Ningbo Unichem Household Products Co., Ltd. 528196956 manufacture
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