Label: ANTIBACTERIAL FOAMING PLUMERIA- 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 20, 2010

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  • ACTIVE INGREDIENT

    TRICLOSAN 0.6% (ANTIBACTERIAL)

  • USES AND DIRECTIONS

    • USES: FOR WASHING TO DECREASE BACTERIA ON THE SKIN.

    • DIRECTIONS: PUMP INTO DRY HANDS,WORK INTO A LATHER VIGOROUSLY. 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 OR REDNESS DEVELOPS AND LASTS.

    KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

  • PACKAGE FRONT AND BACK LABELS

    7.5 OZ FRONT AND BACK LABELS: meijer8.jpg7.5OZ FRONT AND BACK LABELS

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL FOAMING  PLUMERIA
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-173
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.6000 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-173-08221 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33307/20/2010
    Labeler - MEIJER (006959555)
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