Label: ELYPTOL ANTIMICROBIAL HAND GEL- ethanol gel

  • NDC Code(s): 69343-121-02, 69343-121-03, 69343-121-08, 69343-121-15, view more
    69343-121-16, 69343-121-33, 69343-121-34, 69343-121-42, 69343-121-62
  • Packager: Elyptol Inc.
  • 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 December 19, 2022

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Uses

    • To decrease bacteria on skin.
    • Recommended for repeated use.
  • Warnings

    For external use only.

    Flammable. Keep away from sources of fire 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

    redness or irritation develops. If issues persist, seek medical attention.

    Keep out of reach of children.

    If swallowed, seek medical advice or contact a Poison Control Center immediately.

  • Directions

    • Apply Elyptol liberally onto palm of hand.
    • Cover hands with product by thoroughly rubbing and allow to air dry without wiping.
    • Use undiluted.
    • Supervise children under 6 years.
    • Not recommended for infants.
  • Other Information

    • Store below 86°F/30°C.
    • Keep out of direct sunlight.

  • Inactive ingredients

    Aqua (Purified Water), Eucalyptol, Glycerin, Hydroxypropylcellulose, Piroctone Olamine

  • Questions?

    (888) 424-9874

  • SPL UNCLASSIFIED SECTION

    ANTIMICROBIAL
    MOISTURIZING
    HAND SANITIZER GEL

    NATURAL INGREDIENTS

    with EUCALYPTUS OIL

    KILLS 99.9999% OF GERMS

    NO NEED TO RINSE

    SAFE FOR HIGH FREQUENCY USE

    We Think Naturally™

    The Perfect Synergy of Science and Nature

    • No Toxic Chemicals

    • Gentle on Your Skin

    • Not Tested on Animals

    • Dermatologically Tested

    • Environmentally Friendly

    • Ingredients Derived from All Natural Sources and Eucalyptus Oil

    • Kills 99.9999% of Most Common Germs

    Elyptol is the natural choice using Nature’s germ killers in harmony with your skin

    • Elyptol with Eucalyptus Oil helps minimize the likelihood of allergic reactions, contact dermatitis, or dry, cracked skin.

    • Skin is sanitized and moisturized using Elyptol’s formula made without any toxic ingredients.

    • Our products perform to the highest standards recognized for home, office and hospital use.

    100% BIO-BASED INGREDIENTS
    BOTANICAL: Ethanol (Alcohol - processed from corn and/or sugar cane), Eucalyptol (pure eucalyptus oil), Vegetable Glycerin, Hydroxypropylcellulose.
    NATURAL: Aqua (Purified Water).
    OTHER: Piroctone Olamine.

    Elyptol is gentle on your skin yet powerful enough to kill 99.9999% of germs.

    Dermatologically Tested.
    Not Tested On Animals.
    Environmentally Friendly

    Please dispose of empty container in recycle bin.

    Responsibly made in USA
    Manufactured for Elyptol™
    Elyptol Inc.
    Santa Monica, CA 90404 USA
    www.elyptol.com
    (888) 424-9874

    Cruelty Free

    Please Recycle

    Vegan

    Gluten Free

    EWG VERIFIED • EWG.ORG • FOR YOUR HEALTH

  • Packaging

    image description

    image description

  • INGREDIENTS AND APPEARANCE
    ELYPTOL ANTIMICROBIAL HAND GEL 
    ethanol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69343-121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL7 mL  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    PIROCTONE OLAMINE (UNII: A4V5C6R9FB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69343-121-1524 in 1 CARTON11/13/2020
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69343-121-021 in 1 CARTON11/01/2014
    259 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:69343-121-626 in 1 CARTON11/13/2020
    359 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:69343-121-031 in 1 CARTON11/01/2014
    489 mL in 1 PACKAGE; Type 0: Not a Combination Product
    5NDC:69343-121-081 in 1 CARTON11/01/2014
    5236 mL in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:69343-121-161 in 1 CARTON11/01/2014
    6473 mL in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:69343-121-331 in 1 CARTON11/13/2020
    71000 mL in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:69343-121-341 in 1 CARTON11/01/2014
    81005 mL in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:69343-121-421 in 1 CARTON11/13/2020
    91250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/01/2014
    Labeler - Elyptol Inc. (079594781)
    Establishment
    NameAddressID/FEIBusiness Operations
    220 Laboratories LLC.783247950manufacture(69343-121)
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