Label: DERMACEN ANTIMICROBIAL-T HAND- triclosan liquid

  • 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 July 7, 2011

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  • ACTIVE INGREDIENT

    Active Ingredients

    Triclosan 0.375%

  • PURPOSE

    Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Uses

    An effective antimicrobial hand cleanser

    Kills and inhibits bacterial growth on hands

    Gentle cleansers leave hands clean and moisturized

    Reduces the possibility of cross-contamination

  • WARNINGS

    Warnings

    For External Use Only

    When using this product

    Avoid contact with eyes

    Discontinue use if irritation occurs

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    Use as you would any liquid hand soap.

    Wet hands with water, then apply a small amount of product to palm.

    Rub hands together vigorously for at least 15 seconds.

    Rinse and dry thoroughly.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Purified Water, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Lauramide DEA, Cocamide DEA, Cocamidopropyl Betaine, Sodium Cumene Sulfonate, Propylene Glycol, Citric Acid, Sodium Chloride, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 5, Red 4

  • PRINCIPAL DISPLAY PANEL

    DermaCen

    Antimicrobial-T

    Hand Soap

    An antimicrobial

    hand soap to decrease

    bacteria on the skin

    Net Contents: 18 ounces (531 mL)

    container label

  • INGREDIENTS AND APPEARANCE
    DERMACEN ANTIMICROBIAL-T HAND 
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62654-230
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.375 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CUMENESULFONATE (UNII: 5798KA13PG)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62654-230-14251 mL in 1 BOTTLE, PLASTIC
    2NDC:62654-230-37531 mL in 1 BOTTLE, PLASTIC
    3NDC:62654-230-36800 mL in 1 BOTTLE, PLASTIC
    4NDC:62654-230-901000 mL in 1 BOTTLE, PLASTIC
    5NDC:62654-230-911000 mL in 1 BOTTLE
    6NDC:62654-230-921250 mL in 1 BOTTLE, PLASTIC
    7NDC:62654-230-932000 mL in 1 BOTTLE, PLASTIC
    8NDC:62654-230-013785 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2001
    Labeler - Central Solutions Inc (007118524)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Solutions Inc007118524manufacture