Label: MENTHOLATUM MOISTURIZING HAND SANITIZER- benzalkonium chloride gel

  • NDC Code(s): 10742-0004-1
  • Packager: The Mentholatum Company
  • 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 January 18, 2023

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  • Active ingredients

    Benzalkonium Chloride 0.13%

  • Purpose

    Skin antiseptic

  • Uses

    • Hand sanitizer to reduce bacteria on the skin
  • Warnings

    For external use only

    When using this product

    • do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if

    • irritation or rash appears and lasts.

    Keep out of reach of children.

  • Directions

    • Liberally apply product in your palm to thoroughly cover your hands
    • Rub hands together briskly until absorbed.
    • Children under 6 years of age should be supervised when using this product.
  • Inactive ingredients

    purified water, hydroxypropyl starch phosphate, lauryl glucoside, dimethicone, chlorphenesin, edetate disodium, glycerin, hyaluronic acid, methyl gluceth-20, phenoxyethanol, polyquaternium-7, rosmarinus officinalis (rosemary) leaf oil, silanetriol

  • Questions?

    1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

  • Package/Label Principal Display Panel

    Mentholatum Moisturizing Hand Sanitizer
  • Principal Display Panel

    Drug Facts
  • INGREDIENTS AND APPEARANCE
    MENTHOLATUM MOISTURIZING HAND SANITIZER 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-0004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDROXYPROPYL DISTARCH PHOSPHATE, HIGH AMYLOSE CORN (UNII: 9F8ET54T05)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    SILANETRIOL (UNII: E52D0J3TS5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-0004-1192 mL in 1 BOTTLE; Type 0: Not a Combination Product06/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/12/2020
    Labeler - The Mentholatum Company (002105757)
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