Label: ASSURED INSTANT HAND SANITIZER- alcohol spray

  • 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 28, 2016

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  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredient                                            Purpose

    Ethyl Alcohol 62 percent                              Antiseptic

  • PURPOSE

    Uses

    For hand washing to decrease bacteria on the skin

    Recommended for repeated use

  • WARNINGS

    Warnings

    Flammable. Keep away from heat and flame.

    For external use only.

  • STOP USE

    Discontinue use if irritation and redness develops. If condition persists for more than 72 hours consult a doctor.

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    Wet hands thoroughly with product and allow to dry without wiping

    Children under 6 years of age should be supervised when using this product

    Not recommended for infants

  • STORAGE AND HANDLING

    Other information

    Do not store above 105 degrees F

    May discolor some fabrics

  • INACTIVE INGREDIENT

    Aloe barbadensis, FD and C Blue 1 , Fragrance , PEG 18 Dimethicone,

    Tocopheryl Acetate, Water, FD and C Yellow 5

  • DESCRIPTION

    Tamper Evident Statement Here

    Lot Number:                     Expiration Date:

    See outer container for Drug Facts Information


    976139      92

    DISTRIBUTED BY:

    GREENBRIER INTERNATIONAL, INC.

    Chesapeake , VA 23320

    MADE IN CHINA



  • INDICATIONS & USAGE

    Kills 99.99 percent of Germs that may cause disease

    Use anywhere without the need for water

    75 plus sprays per bottle

  • OTHER SAFETY INFORMATION

    ASSURED

    Kills 99.99 percent of Germs

    Instant Hand Sanitizer Spray

    Over 75 sprays

    Aloe and Vitamin E

    convenient size

    pocket, purse , travel , gym , office

    Leaves hands feeling soft and refreshed



    0.34 fl oz

    10mL

  • PRINCIPAL DISPLAY PANEL

    HandSanitizer10ml

  • INGREDIENTS AND APPEARANCE
    ASSURED INSTANT HAND SANITIZER 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-4250
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-4250-110 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/23/201009/28/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/23/2010
    Labeler - Greenbrier International, Inc. (610322518)
    Registrant - Jiangsu Longliqi Bioscience Co., Ltd. (421547530)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiangsu Longliqi Bioscience Co., Ltd.421547530manufacture(33992-4250)
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