Label: DERMACEN NON-ALCOHOL FOAMING HAND SANITIZER- benzalkonium chloride solution

  • NDC Code(s): 62654-141-14, 62654-141-16, 62654-141-37
  • Packager: Central Solutions 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 January 28, 2023

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  • ACTIVE INGREDIENT

    Active ingredient

    Benzalkonium Chloride 0.13%

  • INDICATIONS & USAGE

    Uses

    For hand sanitizing to decrease bacteria on the skin

    Recommended for repeated use

  • WARNINGS

    Warnings

    For external use only

    When using this product avoid contact with eyes.

    In case of eye contact, flush with water.

    Stop use and ask a doctor if irritation or redness develops, or if conditions persists for more than 72 hours.

    Keep out of reach of children. If swallowed, call a physician or Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Pump a small amount of foam into palm of hand

    Rub thoroughly over all surfaces of both hands

    Rub hands together briskly until dry

  • INACTIVE INGREDIENT

    Inactive ingredients

    Purified Water, Glycerin, Cocamidopropyl Betaine, Triethanolamine

  • PURPOSE

    Purpose

    Hand Sanitizer

  • PRINCIPAL DISPLAY PANEL

    DermaCen

    Non-Alcohol

    Foaming Instant

    Hand Sanitizer

    For hand sanitizing

    to decrease bacteria

    on the skin

    NET CONTENTS: 18 ounces (532 mL)

    container label

  • INGREDIENTS AND APPEARANCE
    DERMACEN NON-ALCOHOL FOAMING HAND SANITIZER 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62654-141
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62654-141-14532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/18/2010
    2NDC:62654-141-161000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/18/2010
    3NDC:62654-141-37532 mL in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/18/2010
    Labeler - Central Solutions Inc (007118524)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Solutions Inc007118524manufacture(62654-141)
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