Label: DERMACEN ANTIMICROBIAL-B HAND- benzethonium chloride solution

  • 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 April 9, 2018

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  • ACTIVE INGREDIENT

    Active ingredient:

    Benzethonium Chloride 0.13%

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    For handwashing to decrease bacteria on the skin.

  • WARNINGS

    Warnings

    For External Use Only.

    Do not use in the eyes.

    Discontinue use if irritation and redness develops.

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    Apply to hands and wet as needed.

    Lather vigorously for at least 15 seconds.

    Wash skin, rinse thoroughly and dry.

  • STORAGE AND HANDLING

    Other information

    Protect from freezing.Avoid excessive heat.

    Store at 40-95 F (4-35 C)

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Purified Water, Lauramine Oxide,Lauramidopropylamine Oxide, PEG-150 Distearate, Cocamide MEA, Glycerin, Cetrimonium Chloride, Fragrance, DMDM Hydantoin, Iodopropynyl Carbamate, Citric Acid, Yellow 5, Red 4, (may contain Sodium Hydroxide, Sodium Chloride).

  • QUESTIONS

    Questions?

    Call 800-255-0262

  • PRINCIPAL DISPLAY PANEL

    DermaCen

    Antimicrobial-B

    Hand Soap

    An antimicrobial

    hand soap for healthcare

    professionals to decrease

    bacteria on the skin

    Net Contents:

    9 oz (266mL)

    container label

  • INGREDIENTS AND APPEARANCE
    DERMACEN ANTIMICROBIAL-B HAND 
    benzethonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62654-232
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62654-232-09266 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/09/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/09/2018
    Labeler - Central Solutions Inc (007118524)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Solutions Inc007118524manufacture(62654-232)
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