Label: MOLCHEM HAND PURIFIER- benzalkonium chloride spray

  • NDC Code(s): 80606-001-01, 80606-001-02, 80606-001-03, 80606-001-04, view more
    80606-001-05, 80606-001-06, 80606-001-07
  • Packager: MOL BELTING SYSTEMS, 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 June 9, 2023

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  • Warnings

    For external use only.

    When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse thoroughly
    with water.

    Stop use and ask a doctor if irritation or rash occurs. This may be a sign of a serious condition.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Other information

    Store in dry place between 35° and 103°F

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together.

    • Supervise children under 6 years of age when using this product to avoid swallowing.

  • Uses

    • To decrease bacteria on the skin.

    • Recommended for repeated use.

    • For use when soap and water are not available

  • Inactive ingredients

    Deionized Water, Propylene glycol, Triethylene glycol, Phospholipids Complex, Organo Silane Quaternaries

  • Active ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antiseptic

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    MOLCHEM HAND PURIFIER 
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80606-001
    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
    DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TRIETHYLENE GLYCOL (UNII: 3P5SU53360)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80606-001-0159.14 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/15/2021
    2NDC:80606-001-02236.58 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/15/2021
    3NDC:80606-001-033785.41 mL in 1 DRUM; Type 0: Not a Combination Product07/15/2021
    4NDC:80606-001-0418927.1 mL in 1 DRUM; Type 0: Not a Combination Product07/15/2021
    5NDC:80606-001-05208198 mL in 1 DRUM; Type 0: Not a Combination Product07/15/2021
    6NDC:80606-001-061040987.75 mL in 1 JUG; Type 0: Not a Combination Product07/15/2021
    7NDC:80606-001-07500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/15/2021
    Labeler - MOL BELTING SYSTEMS, INC (147753685)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mol Belting Systems Inc147753685pack(80606-001)
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