Label: ANTIBACTERIAL FOAMING POMEGRANATE- triclosan liquid

  • 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 0.46% (ANTIBACTERIAL)

  • USES AND DIRECTIONS

    • USES: HELPS REDUCE BACTERIA ON THE SKIN.
    • DIRECTIONS:PUMP ONTO DRY HANDS. LATHER VIGOROUSLY FOR AT LEAST 15 SECONDS. RINSE AND DRYTHOROUGHLY.
  • WARNINGS

    • FOR EXTERNAL USE ONLY. KEEP OUT OF REACH OF CHILDREN. IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

    WHEN USING THIS PRODUCT

    • AVOID CONTACT WITH EYES, IF CONTACT OCCURS, RINSE WITH WATER.

    STOP USING THIS PRODUCT AND ASK A DOCTOR

    • IF IRRITATION OR RASH DEVELOPS AND LASTS.
  • PACKAGE FRONT AND BACK LABELS

    7.5OZ FRONT AND BACK LABELS: care8.jpg7.5OZ FRONT AND BACK LABELS

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL FOAMING  POMEGRANATE
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-164
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.4600 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63148-164-08221 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33307/06/2010
    Labeler - Apollo Health and Beauty Care (201901209)
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Safety

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