Label: ROUGH AND SMOOTH HEAVY DUTY ANTISEPTIC HAND SANITIZER- benzalkonium chloride cloth

  • NDC Code(s): 90119-001-02, 90119-001-40, 90119-001-80
  • Packager: Orbizorb LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 26, 2023

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  • Drug Facts

  • Active ingredient

    Benzalkonium chloride 0.13%

    Purpose

    Antiseptic

  • Use

    • For hand washing to decrease bacteria on the skin
  • Warnings

    For external use only

    Do not use

    in the eyes

    Stop use and ask a doctor if

    • irritation and redness develop.
    • If condition persists for more than 72 hours consult a doctor.

    Keep out of reach of children.

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

  • Directions

    • Peel back the foil seal and pull the center wipe through the slot in the lid.
    • Wet hands thoroughly with product and allow to dry without wiping.
    • Close lid after use to prevent wipes from drying out.
  • Inactive ingredients

    Water, Estasol, Poloxalene, PEG-75 Lanolin, Glycerin, Aloe Barbadensis Extract, Polyethylene glycol, Lauryl Glycosides, Fragrance, Disodium EDTA, 2-bromo-2-nitropropane-1,3-diol, 1,2-benzisothiazolin-3-one.

  • Package Labeling:

    Updated 80ct Label

  • Package Labeling:2wipes

    Label

  • Package Labeling:40wipes

    Label2

  • INGREDIENTS AND APPEARANCE
    ROUGH AND SMOOTH HEAVY DUTY ANTISEPTIC HAND SANITIZER 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90119-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLOXALENE (UNII: V8B3K56SW0)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    BRONOPOL (UNII: 6PU1E16C9W)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:90119-001-8080 in 1 CANISTER08/30/2020
    1612.48 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:90119-001-022 in 1 PACKAGE09/20/2020
    27.656 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    3NDC:90119-001-4040 in 1 PACKAGE09/20/2020
    37.656 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)08/30/2020
    Labeler - Orbizorb LLC (117447551)
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