Label: MUKELIR ANTIBACTERIAL LIQUID FOR WASHING HANDS WITH ROCK SALT- hand sanitizer gel

  • Category: HUMAN OTC DRUG LABEL

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 May 12, 2020

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  • Active Ingredient(s)

    0.20% Benzalkonium choride Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    The product is a topical product, which is suitable for cleaning and bacteriostasis of hand skin.

  • Warnings

    Please suspend the use if there is any exception during the use.

    Keep out of reach of infnants and young children.

  • Do not use

    Please suspend the use if there is any exception during the use.

  • WHEN USING

    Keep out of reach of infnants and young children.

  • STOP USE

    Please suspend the use if there is any exception during the use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of infnants and young children.

  • Directions

    gently press the pump head, press out an appropriate amount of this product in the hand, fully rub the fingernails of palm between the fingers and rinse with water

  • Other information

    Store in a cool place at room temperature to avoid sunshine.

  • Inactive ingredients

    Sodium chloride, Sodium lauryl sulfate, Cocamidopropyl Betaine, C12-14 Sodium olefin sulfonate, Benzalkonium choride, Propylene glycol, glycerin, EDTA Disodium, essence, CL42090, purified water    

  • Package Label - Principal Display Panel

    500 mL NDC: 76620-002-01

    PDP

  • INGREDIENTS AND APPEARANCE
    MUKELIR ANTIBACTERIAL LIQUID FOR WASHING HANDS WITH ROCK SALT 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76620-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM C14 OLEFIN SULFONATE (UNII: N816E2SOKI)  
    ACACIA SENEGAL FLOWER (UNII: 72P931MTC2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76620-002-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/23/2020
    Labeler - Pingmei Shenma Group Henan Tianjian Daily Chemical Co., Ltd. (411229864)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pingmei Shenma Group Henan Tianjian Daily Chemical Co., Ltd.411229864manufacture(76620-002)
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