Label: ELYPTOL LIGHT SCENT- ANTIMICROBIAL HAND GEL- ethanol gel

  • NDC Code(s): 69343-421-01, 69343-421-02, 69343-421-08, 69343-421-15, view more
    69343-421-16, 69343-421-32, 69343-421-42
  • 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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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient:

    Ethyl Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Keep out reach of children

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

  • 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.

  • 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

    Questions?(888) 424-9874

  • SPL UNCLASSIFIED SECTION

    Moisturizing Hand Sanitizer

    NATURAL INGREDIENTS

    SUITABLE FOR HIGH FREQUENCY USE

    KILLS 99.99% of GERMS

    NO NEED TO RINSE

    Dermatologically Tested

    Not Tested On Animals

  • Packaging

    15ml (0.5 fl oz)2ml (0.06 fl oz)144 count - 2ml (0.06 fl oz)image description

  • INGREDIENTS AND APPEARANCE
    ELYPTOL LIGHT SCENT- ANTIMICROBIAL HAND GEL 
    ethanol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69343-421
    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 (1600000 WAMW) (UNII: RFW2ET671P)  
    PIROCTONE OLAMINE (UNII: A4V5C6R9FB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69343-421-021 in 1 CARTON06/01/2016
    159 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69343-421-081 in 1 CARTON06/01/2016
    2236 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:69343-421-161 in 1 CARTON06/01/2016
    3473 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:69343-421-321 in 1 CARTON06/01/2016
    4946 mL in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:69343-421-011 in 1 CARTON01/13/2017
    52 mL in 1 PACKET; Type 0: Not a Combination Product
    6NDC:69343-421-151 in 1 CARTON01/13/2017
    615 mL in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:69343-421-421 in 1 CARTON06/01/2016
    71242 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2016
    Labeler - ELYPTOL INC. (079594781)
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