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 January 1, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Alcohol 70% v/v

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    to help reduce bacteria on skin

  • WARNINGS

    Warnings

    For external use only

    Flammable, keep away from heat or flame.

    When using this product keep away from eyes. In case of eye contact, rinse eyes with water.

    Stop use and ask a doctor if irritation or redness develop or last more than 72 hours.

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

  • DOSAGE & ADMINISTRATION

    Directions

    • apply liberally to hands to cover all surfaces
    • rub hands together until dry
    • supervise children under 6 years old
    • not recommended for infants
  • SPL UNCLASSIFIED SECTION

    Other information

    • store between 15-30°C (59-86°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    glycerin, hydrogen peroxide, purified water, acrylates/C10-30 alkyl acrylate crosspolymer, aminomethyl propanol, lauryl lactate, fragrance

  • SPL UNCLASSIFIED SECTION

    Distributed by LumAware

    Cincinnati, OH 45219

    Questions? Call 513-761-7614

  • PRINCIPAL DISPLAY PANEL

    ClearGuard

    Hand Sanitizer

    Alcohol Based

    2 FL OZ (59 mL)

    label

  • INGREDIENTS AND APPEARANCE
    CLEARGUARD HAND SANITIZER 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80996-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    LAURYL LACTATE (UNII: G5SU0BFK7O)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80996-002-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/01/2021
    Labeler - EVP International, LLC (965692812)
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