Label: LILKOI HAND SANITIZING WIPES- 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 November 2, 2021

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  • Active Ingredient

    Alcohol 80% v/v. 

  • Purpose

    Antiseptic skin cleanser

  • Uses

    For personal hand hygiene to help prevent the spread of bacteria.

  • Warnings

    For external use only. 
    When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.
    Stop use and consult a healthcare professional if irritation develops.

    Flammability warning: Flammable. Keep away from open flame and sources of heat.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    Adults and children over 2 years. For occasional and personal domestic use. Supervise children when they use this product. Rub thoroughly into hands for at least 30 seconds. Allow to dry.

  • Other information

    • Store at 68-70  0F (20-25 0C)
    • May discolor certain fabrics or surfaces.
  • Inactive ingredients

    Water, Isopropyl alcohol, Glycerin, Hyaluronic Acid, Bergamot leaf oil, Lavender Flower Oil, Hydrogen Peroxide, Centella Asiatica Extract, Sodium pyruvate

  • Package Label - Principal Display Panel

    Label 2Label 2

  • INGREDIENTS AND APPEARANCE
    LILKOI HAND SANITIZING WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75306-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    SODIUM PYRUVATE (UNII: POD38AIF08)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75306-010-011 in 1 POUCH06/01/2020
    12 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    2NDC:75306-010-0210 in 1 POUCH06/01/2020
    22 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    3NDC:75306-010-0320 in 1 POUCH06/01/2020
    32 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    4NDC:75306-010-0450 in 1 POUCH06/01/2020
    42 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    5NDC:75306-010-05100 in 1 POUCH06/01/2020
    52 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    6NDC:75306-010-06250 in 1 POUCH06/01/2020
    62 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    7NDC:75306-010-0750 in 1 CONTAINER06/01/2020
    72 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    8NDC:75306-010-08100 in 1 CONTAINER06/01/2020
    82 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    9NDC:75306-010-09250 in 1 CONTAINER06/01/2020
    92 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2020
    Labeler - D-Time Limited Liability Company (081728006)
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