Label: ALCOHOL FREE HAND SANITIZER- benzalkonium chloride gel

  • NDC Code(s): 70412-120-10, 70412-120-30
  • Packager: Zhejiang Ayan Biotech Co.,Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 27, 2024

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  • Drug Facts

  • Active ingredient

    Benzalkonium Chloride 0.1 %

    Purpose

    Antibacterial

  • Uses:

    For Hand Sanitizing

  • Warnings:

    For external use only.

    When using this product

    Keep out of eyes.

    Stop use and ask doctor if

    irritation and redness develops and persists.

    Keep out of reach of children.

  • Directions:

    Wet hands throughly with product and allow to dry without wiping.

  • Other Information:

    Store under 105° F.

  • Inactive ingredients:

    Citric Acid, Diazolidinyl Urea, Fragrance, PEG-60 Hydrogenated, Castor Oil, Polyquaternium-10,Water(Aqua)

  • Questions or Comment?

    www.tekweld.com

  • Package Labeling:70412-120-10

    Inner Label

  • Package labeling: 70412-120-30

    label2

  • INGREDIENTS AND APPEARANCE
    ALCOHOL FREE HAND SANITIZER 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70412-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70412-120-101 in 1 BOX01/18/201610/31/2025
    110 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:70412-120-301 in 1 BOX01/18/201601/19/2016
    230 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)01/18/201610/31/2025
    Labeler - Zhejiang Ayan Biotech Co.,Ltd. (544377996)