Label: HAND ESSENTIALS ANTIBACTERIAL- triclosan soap

  • 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 February 19, 2015

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  • Active ingredient

    Triclosan 0.5%

  • Purpose

    Antiseptic Handwash

  • Uses

    •
    For handwashing to decrease bacteria on skin
  • Warnings

    For external use only.

    When using this product

    •
    avoid contact with eyes. In case of eye contact, flush with water.

    Stop use and ask a doctor if

    •
    irritation or redness develop
    •
    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 into wet hands
    •
    lather vigorously for at least 15 seconds
    •
    rinse and dry thoroughly
  • Inactive ingredients

    Water, Ammonium Lauryl Sulfate, Sodium Laureth Sulfate, Sodium Chloride, Cocamide DEA, Disodium Cocamido MIPA Sulfosuccinate, Glycerin, Polyquaternium-7, DMDM Hydantoin, BHT, Fragrance, Tetrasodium EDTA, Glutamic Acid, Leucine, Serine, Phenylalanine, Proline, Glycine, Valine, Isoleucine, Arginine, Citric Acid., Yellow 5, Red 33

  • Package/Label Principal Display Panel

    Hu-Friedy Hand Essentials Antibacterial Soap

    Hu-Friedy

    HAND ESSENTIALS

    Antibacterial Soap

    Effective against bacteria, yet gentle enough for frequent use.

    Part-code: IMS-1506

    MADE IN USA

    Hu-Friedy

    16 Fl oz (473 mL)

  • INGREDIENTS AND APPEARANCE
    HAND ESSENTIALS ANTIBACTERIAL 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65626-017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.5 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    POLYQUATERNIUM-7 (76/24 ACRYLAMIDE/DADMAC; 120000 MW) (UNII: AAJ238UT03)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    LEUCINE (UNII: GMW67QNF9C)  
    SERINE (UNII: 452VLY9402)  
    PHENYLALANINE (UNII: 47E5O17Y3R)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    GLYCINE (UNII: TE7660XO1C)  
    VALINE (UNII: HG18B9YRS7)  
    ISOLEUCINE (UNII: 04Y7590D77)  
    ARGININE (UNII: 94ZLA3W45F)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65626-017-06473 mL in 1 BOTTLE, PUMP
    2NDC:65626-017-04118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/01/2010
    Labeler - HU-FRIEDY MFG. CO., INC. (005085972)
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