Label: HEALTH SMART ANTIBACTERIAL LAVENDER CHAMOMILE- triclosan 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 December 24, 2013

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  • Drug Facts

    Active Ingredients

    Triclosan 0.15%

  • Purpose

    Antibacterial

  • Uses

    for hand washing to help eliminate bacteria on the skin.

  • Warnings

    for external use only.

  • WHEN USING

    When using this product avoid contact with eyes. If case of eye contact, flush with water.

  • STOP USE

    Stop use and ask a doctor if: irritation and redness develops.

  • 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.

  • Directions

    • pump into hands
    • lather vigorously for at least 15 seconds
    • rinse and dry thoroughly.
  • Other information:

    store at room temperature.

  • Inactive ingredients

    Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Sodium Chloride, Fragrance, Glycerin, Citric Acid, PEG-150 Distearate, Methylchloroisothiazolinone, Methylisothiazolinone, FD&C Red No. 33, FD&C Blue No. 1

  • SPL UNCLASSIFIED SECTION

    MADE IN CHINA.

    DISTRIBUTED BY:
    homesmartTM
    PRODUCTS
    SOUTHFIELD, MI 48075
    WWW.HOMESMARTPRODUCTS.COM

  • Package Label

    ELIMINATES BACTERIA •MOISTURIZES SKIN

    HEALTH SMARTTM
    lavender chamomile
    ANTIBACTERIAL
    HAND SOAP
    7.5 FL OZ [221 mL]

    Label

  • INGREDIENTS AND APPEARANCE
    HEALTH SMART ANTIBACTERIAL LAVENDER CHAMOMILE 
    triclosan solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52862-309
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.15 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52862-309-75221 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/24/2013
    Labeler - International Wholesale, Inc. (161872676)
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