Label: HYGIENI-KLEAN HAND SANITIZER FLUID FRESH- alcohol liquid

  • 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 April 20, 2021

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  • Active Ingredients

    Ethanol 75% v/v

  • Purpose

    Antibacterial

  • INDICATIONS & USAGE

    Uses Hand sanitizer to help reduce bacteria on the skin. Recommended for repeated use.

  • WARNINGS

    Warning Flammable. Keep away from fire or flame. For external use only.

  • WHEN USING

    When using this product avoid contact with eyes, ears, and mouth. In case of contact with eyes, flush eyes with water immediately. Avoid contact with broken skin. Discontinue use if irritation or redness develops. If condition persists, consult a doctor.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Children should only use this product under adult supervison. Do not drink. Not edible. In case of accidential ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • STORAGE AND HANDLING

    Other Information Store under 105°F. 

  • DOSAGE & ADMINISTRATION

    Directions Place hand sanitizer in your palm, thoroughly cover hands, including between fingers, under fingernails, and around wrists. Rub briskly until dry. No rinsing required.

  • INACTIVE INGREDIENT

    Inactive Ingredients Purified water, Glycerin USP, PEG-600, Fragrance

  • PRINCIPAL DISPLAY PANEL

    01 - 1 gallon:

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    02-32 oz:

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    03-16 oz:

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    04-12 oz:

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    05-8 oz:

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    06-4 oz:

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    07-2 oz:

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  • INGREDIENTS AND APPEARANCE
    HYGIENI-KLEAN HAND SANITIZER FLUID FRESH 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78174-017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75.0271 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 0.067 L  in 100 L
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) 0.0409 L  in 100 L
    water (UNII: 059QF0KO0R) 24.7832 L  in 100 L
    FRAGRANCE CUCUMBER ALOE ORC1802955 (UNII: FSS3TH6V9M) 0.0818   in 100 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78174-017-013.78541 L in 1 JUG; Type 0: Not a Combination Product04/20/2021
    2NDC:78174-017-020.946353 L in 1 BOTTLE; Type 0: Not a Combination Product04/20/2021
    3NDC:78174-017-030.473176 L in 1 BOTTLE; Type 0: Not a Combination Product04/20/2021
    4NDC:78174-017-040.354882 L in 1 BOTTLE; Type 0: Not a Combination Product04/20/2021
    5NDC:78174-017-050.236588 L in 1 BOTTLE; Type 0: Not a Combination Product04/20/2021
    6NDC:78174-017-060.118294 L in 1 BOTTLE; Type 0: Not a Combination Product04/20/2021
    7NDC:78174-017-070.0591471 L in 1 BOTTLE; Type 0: Not a Combination Product04/20/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/20/2021
    Labeler - Custom Chemical Services, LLC (078305908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Chemical Services, LLC078305908manufacture(78174-017)
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