Label: HOLIDAY ELEGANCE- 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 September 25, 2013

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  • INACTIVE INGREDIENT

    Inactive Ingredients: Aloe Barbadensis Leaf

    Extract, Benzophenone - 4, Blue 1, Cocomide DEA,

    Cocomidopropyl Betaine, Citric Acid, Disodium EDTA,

    DMDM Hydantoin, Methylchlorisothiazolinone, Parfum,

    Propolene Glycol, Red 33, Retinyl Palmitate, Sodium

    Laureth Sulfate, Tocoperyl Acetate, Water (Aqua)

    Yellow 5

  • ACTIVE INGREDIENT

    Active Ingredient:

    Triclosan 0.3 %

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Use - Handwashing to decrease bacteria

    on skin

  • WARNINGS

    Warnings

    For external use only.

  • WHEN USING

    When using this product, avoid contact

    with eyes. If contact occurs, rinse thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation and

    redness develop.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed,

    get medical help or contact a Poison Control Center

    right away.

  • DOSAGE & ADMINISTRATION

    Directions - wet hands, work into rich

    lather - rinse well

  • QUESTIONS

    Questions?  1 - 800 - FDA - 1088

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    HOLIDAY ELEGANCE 
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53057-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN.9 g  in 300 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZOPHENONE (UNII: 701M4TTV9O)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53057-004-0112 in 1 BOX
    1121 g in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/01/2013
    Labeler - Triz Laboratories Ltd. (421290822)
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