Label: KLEAN PLUS INSTANT HAND SANITIZER TEA TREE SCENT- ethanol gel

  • 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 7, 2020

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Ethanol 65%

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

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

  • WARNINGS

    Warnings Flammable, keep away from fire/flame

    For external use

    Do not use • in children less than 2 months of age • on open skin

    When using this product 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.

  • DOSAGE & ADMINISTRATION

    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

  • STORAGE AND HANDLING

    Other information • store between 15-30°C (59-86°F) • avoid freezing and excessive heat above 40°C (104°F) • tamper evident

  • INACTIVE INGREDIENT

    Inactive ingredients water, extra virgin coconut oil, xanthan gum, glycerin, nipagin, nipasol, EDTA-4Na, tea tree essential oil

  • QUESTIONS

    Questions? +1-800-674-3263

    You may also report serious side effects to this phone number.

    Mon-Fri 9:00 AM - 5:00 PM

  • SPL UNCLASSIFIED SECTION

    KLEANER For A Healthier Life

    ANTIBACTERIAL

    TEA TREE SCENT

    hand crafted in small batches designed for daily use 

    Distributed by:

    Chiavaye LLC

    Denver, CO 80209

    kleanhandsanitizer.com

    Customer Service:

    support@kleanhandsanitizer.com

    Manufactured for: Klean + Hand Sanitizer, PO Box 9751 225 S Broadway, Denver, CO 80209

    Made in Vietnam

  • Packaging

    Klean1

  • INGREDIENTS AND APPEARANCE
    KLEAN PLUS INSTANT HAND SANITIZER TEA TREE SCENT 
    ethanol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74025-444
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74025-444-9090 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/06/2020
    Labeler - CATCHERS INTERNATIONAL LIMITED LIABILITY COMPANY (556673620)
    Establishment
    NameAddressID/FEIBusiness Operations
    CATCHERS INTERNATIONAL LIMITED LIABILITY COMPANY556673620manufacture(74025-444)
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