Label: DERMA-SAN- benzalkonium chloride liquid

  • NDC Code(s): 63131-0006-1
  • Packager: Anderson Chemical 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 May 1, 2020

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  • Active ingredient

    Benzalkonium Chlorine, 0.1% w/v

  • Purpose

    Antimicrobial

  • Use

    • For handwashing to decrease bacteria on skin
    • Recommended for repeated use
  • Warning

    For external use only

  • When using this product

    • avoid contact with eyes.
    • in case on eye contact, flush eyes with water
  • Stop use and ask a doctor if

    • irritation or redness develops or if condition persists for more than 72 hours.
  • Keep out of reach of children.

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

    • Pump a small amounts of foam into palm of hand.
    • Rub thoroughly over all surfaces of both hands.
    • Rub hands together briskly until dry.
  • Inactive ingredients

    Water, cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, and citric acid.

  • Questions or comment?

    320-693-2477

  • Principal Display Panel

    Derma-San

    NO-RINSE HAND SANITIZER

    NET CONTENTS: 1 US GALLON

    ProductLabel

  • INGREDIENTS AND APPEARANCE
    DERMA-SAN 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63131-0006
    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
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63131-0006-17570 in 1 CASE05/20/2008
    13785 mL in 1 JUG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/20/2008
    Labeler - Anderson Chemical Company (006179220)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anderson Chemical Company006179220manufacture(63131-0006)