Label: ANTISEPTIC HAND SANITIZER FOAM- ethyl alcohol aerosol, foam

  • 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 March 22, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • Uses

    • hand sanitizer to decrease bacteria on the skin
    • recommended for repeated use
    • for use when soap and water are not available
  • Warnings

    Flammable, keep away from fire/flame

    For external use only

    Do not use

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

    When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

    Stop use and ask a doctor if

    • irritation and redness develop
    • condition persists 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 and allow to dry without wiping
    • supervise children under 6 years of age when using this product to avoid swallowing
  • Other information

    • store between 15-30°C (59-86°F)
    • avoid freezing and excessive heat above 40°C (104°F)
    • do not reuse container. Dispose of properly
  • Inactive ingredients

    Water, Glycerol, PEG-10 Dimethicone

  • Questions?

    +1-800-535-5053

    You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

  • SPL UNCLASSIFIED SECTION

    Since H 1923

    Antiseptic

    HAND SANITIZER

    Foam

    H Higley

    Manufactured by: Higley Industries, Inc. 585 Huff St., Dubuque IA, 52003

    WWW.HIGLEYINC.COM

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC HAND SANITIZER FOAM 
    ethyl alcohol aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65584-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65584-105-1259 mL in 1 BOTTLE; Type 0: Not a Combination Product03/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/19/2020
    Labeler - Higley Industries, Inc. (005467626)
    Establishment
    NameAddressID/FEIBusiness Operations
    Higley Industries, Inc.005467626manufacture(65584-105)
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