Label: KLEAN-75- ethyl alcohol cloth

  • 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 30, 2021

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 75% 

  • Purpose

    Antiseptic

  • Use

    For hand washing to decrease bacteria on the skin.

  • Warnings

    For external use only

    Flammable. Keep away from heat or flame.

    When using this product

    ■ keep out of eyes. In case of contact with eyes, rinse thoroughly with water

    ■ avoid contact with broken skin

    Stop use and ask a doctor if

    ■ irritation and redness develop

    ■ condition persists for more 72 hours

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ■ wet hands thoroughly with product and allow to dry without wiping

    ■ for children under 6, use only under adult supervision

    ■ not recommended for infants

  • Other information

    Store below 43°C(110°F)

  • Inactive ingredients

    Purified water

  • Questions?

    408-241-8880, Paaneeco International

  • SPL UNCLASSIFIED SECTION

    Kills germs

    Good to use within 24 months of manufacturing.

    Use on your hands 

    Manufactured by:

    Paaneeco, Inc.

    1285, Jangjero, Gyeyang-gu,

    Incheon, South Korea

    Keep cover tightly sealed to prevent from drying.

    Made in South Korea

  • Packaging

    KLEAN-75-1KLEAN-75-2

  • INGREDIENTS AND APPEARANCE
    KLEAN-75 
    ethyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90039-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:90039-100-1010 in 1 BOX07/09/2020
    12.4 mL in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:90039-100-3030 in 1 BOX07/09/2020
    22.4 mL in 1 PACKAGE; Type 0: Not a Combination Product
    3NDC:90039-100-6060 in 1 BOX07/09/2020
    32.4 mL in 1 PACKAGE; Type 0: Not a Combination Product
    4NDC:90039-100-00100 in 1 BOX07/09/2020
    42.4 mL in 1 PACKAGE; Type 0: Not a Combination Product
    5NDC:90039-100-2020 in 1 CARTON12/28/2021
    52.4 mL in 1 PACKAGE; Type 0: Not a Combination Product
    6NDC:90039-100-7070 in 1 CARTON12/28/2021
    62.4 mL in 1 PACKAGE; Type 0: Not a Combination Product
    7NDC:90039-100-8080 in 1 CARTON12/28/2021
    72.4 mL in 1 PACKAGE; Type 0: Not a Combination Product
    8NDC:90039-100-55550 in 1 CARTON12/28/2021
    82.4 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/09/2020
    Labeler - Paaneeco, Inc. (689196778)
    Establishment
    NameAddressID/FEIBusiness Operations
    Paaneeco, Inc.689196778manufacture(90039-100)
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