Label: ANTIBACTERIAL HAND- 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 July 6, 2010

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  • Active Ingredient

    Triclosan 0.15% (Anitbacterial)

  • Uses and Directions

    • Uses: For hand washing to decrease bacteria on the skin.
    • Directions: Apply onto wet hands work into a lather rinse thoroughly.
  • Warnings

    For external use only.

    When using this product

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

    Stop using this product and ask doctor

    If irritation and redness develop.

    Keep out of reach of children

    In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • PRINCIPAL DISPLAY PANEL

    • 8OZ FRONT AND BACK LABELS: cvs8.jpg
      7.5 FL OZ
  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND  
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-216
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.1500 mL  in 100.0000 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-216-08221 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33307/06/2010
    Labeler - CVS Pharmacy (062312574)
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