Label: ANTIBACTERIAL HAND SOAP FOR SENSITIVE SKIN- triclosan lotion/shampoo

  • 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 March 8, 2010

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  • ACTIVE INGREDIENT

    Triclosan 0.115 % ............. (Antibacterial)

  • USES

    For washing to decrease bacteria on the skin

  • WARNINGS

    For external use only

    STOP USING THIS PRODUCT AND ASK A DOCTOR IF

    • irritation or redness develops and lasts

    WHEN USING THIS PRODUCT

    • Avoid contact with eyes
    • If contact occurs, rinse eyes throughly with water

    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

    • 64OZ FRONT AND BACK LABELS: hce64.jpg
      64OZ FRONT AND BACK LABELS
    • 8OZ FRONT AND BACK LABELS: hce8.jpg
      8OZ FRONT NAD BACK LABELS
  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SOAP  FOR SENSITIVE SKIN
    triclosan lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-720
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.1150 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-720-641890 mL in 1 BOTTLE, PLASTIC
    2NDC:37808-720-08236 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33303/08/2010
    Labeler - HEB (007924756)