Label: ELYPTOL ANTIMICROBIAL RUB- ethanol solution

  • NDC Code(s): 69343-221-02, 69343-221-03, 69343-221-08, 69343-221-16, view more
    69343-221-34
  • 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 12, 2019

If you are a consumer or patient please visit this version.

  • Active ingredients:

    Ethyl Alcohol 70% v/v

  • Purpose

    Skin antiseptic

  • Keep out reach of children

    • Supervise children under 6 years.
    • Not recommended for infants.
  • Uses

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

    • For external use only

    Flammable.

    • Keep away from sources of fire or flame.
    • If swallowed seek medical advice or contact a Poison Control Center, immediately.

    When using this product

    • Do not ingest or inhale.
    • Keep away from eyes.
    • Use undiluted.

    Stop using and ask a doctor

    • If redness or irritation develops.
    • In case of eye contact, rinse eyes with water.
    • If issues persist, seek medical attention.
  • Directions

    • HAND SANITISER/SKIN ANTISEPTIC: Apply Elyptol evenly and rub for 30 seconds.
    • SURGICAL HAND DISINFECTION: Apply Elyptol from forearms to fingertips. Rub evenly for 3 minutes, including between fingers and over nails.
    • PRE-OPERATIVE SKIN PREPARATION AND SKIN ANTISEPSIS: Apply Elyptol and rub evenly over desired area for 30 seconds.

  • Other Information

    Store below 30°C
    Keep out of direct sunlight.

  • Inactive ingredients

    Eucalyptus oil, Water, Glycerol, Cellulose, Piroctone Olamine.

  • SPL UNCLASSIFIED SECTION

    INT PAT APP NO: PCT/2012/000841

  • Questions?

    (866)701-8344

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    ELYPTOL ANTIMICROBIAL RUB 
    ethanol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69343-221
    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
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PIROCTONE OLAMINE (UNII: A4V5C6R9FB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69343-221-021 in 1 CARTON11/01/2014
    159 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69343-221-031 in 1 CARTON11/01/2014
    289 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:69343-221-081 in 1 CARTON11/01/2014
    3236 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:69343-221-161 in 1 CARTON11/01/2014
    4473 mL in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:69343-221-341 in 1 CARTON11/01/2014
    51005 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
    Universal Packaging Systems, Inc. (DBA: PakLab)790530976manufacture(69343-221)