Label: DERMAPROT TRICLOTREX-B- triclosan liquid

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 August 5, 2012

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  • ACTIVE INGREDIENT

    This product is an antibacterial liquid which produces a synergistic effect between the Triclosan is the active ingredient with a volatile carrier such as alcohol.

  • PURPOSE

    This product is designed to produce an antibacterial effect both in the hands and utensils commonly used as combs and scissors in the facial aesthetics

  • KEEP OUT OF REACH OF CHILDREN

    This product must be keep out of reach of children

  • INDICATIONS & USAGE

    This product is for topical application as well as being used in beauty salons utensils that need to be desinfected before being used.

  • WARNINGS

    If this product to contact with eyes rinse immediately with water and consult a physician.

  • DOSAGE & ADMINISTRATION

    Spray an hands before rubbing them.

  • INACTIVE INGREDIENT

    The active ingredient is in a volatile carrier of alcohol, Aloe Vera extract and glycerin to help form a protective glove on the skin and objects that are using this product.

  • PRINCIPAL DISPLAY PANEL

    IMAGE OF THE LABELIMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    DERMAPROT  TRICLOTREX-B
    triclosan liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66854-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.3 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    DIPYRITHIONE (UNII: 9L87N86R9A)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66854-004-01500 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333E08/30/2012
    Labeler - SAPI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
    Establishment
    NameAddressID/FEIBusiness Operations
    SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS880172184manufacture(66854-004) , analysis(66854-004) , label(66854-004) , pack(66854-004)
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