Label: CLEARGUARD HAND SANITIZER- alcohol solution

  • 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 17, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Alcohol 80% v/v

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    • hand sanitizer to help reduce bacteria that potentially can cause disease
    • for use when soap and water are not available
  • WARNINGS

    Warnings

    For external use only

    Flammable, keep away from heat or flame.

    Do not use

    • in children less than 2 months of age
    • on open skin wounds

    When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

    Keep out of reach of children. If swallowed, get medial help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • place enough product on hands to cover all surfaces
    • rub hands together until dry
    • supervise children under 6 years of age when using this product to avoid swallowing
  • SPL UNCLASSIFIED SECTION

    Other information

    • store between 15-30°C (59-86°F)
    • avoid freezing and excessive heat above 40°C (104°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    glycerin, hydrogen peroxide, purified water USP

  • SPL UNCLASSIFIED SECTION

    www.LumAwareSafety.com/ClearGuard

    Distributed by LumAware Safety • Cincinnati, OH 45219

    Questions? Call 513-761-7614 • www.LumAwareSafety.com/ClearGuard

  • PRINCIPAL DISPLAY PANEL

    ClearGuard™

    HAND SANITIZER

    Alcohol 80% Antiseptic Topical Solution

    100 individual packets

    0.07 fl oz (2ml) each

    ClearGuard 100CT PDPClearGuard Bag Back

  • INGREDIENTS AND APPEARANCE
    CLEARGUARD HAND SANITIZER 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80996-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80996-001-10100 in 1 BAG02/17/2021
    12 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/17/2021
    Labeler - EVP International, LLC (965692812)
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