Label: DIGNITY HEALTH MEDSPA 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 June 9, 2015

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  • Active Ingredient

    Triclosan 0.3%

  • Purpose

    Antibacterial

  • Uses

    for washing to decrease bacteria on the skin.

  • Warnings

    For external use only.

  • When using this product

    Avoid contact with eyes. In case of eye contact, flush with water.

    Don't use this product on infants under 6 months of age.

  • Stop use and ask a doctor

    If irritation and redness develops.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • wet bar with water
    • lather vigorously and wash skin
    • rinse and dry thoroughly.
  • Inactive Ingredients

    Water, calcium carbonate, fragrance, glycerine, sodium chloride, sodium palmate

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    DIGNITY HEALTH MEDSPA ANTIBACTERIAL 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69688-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69688-001-01200 in 1 BOX
    121 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/09/2015
    Labeler - Jiangsu Xinheyuan Plastic Daily Chemical Co., Ltd. (527743312)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiangsu Xinheyuan Plastic Daily Chemical Co., Ltd. 527743312manufacture(69688-001)
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