Label: ANTIBACTERIAL HAND SOAP WITH LIGHT MOISTURIZERS- triclosan lotion

  • 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 February 24, 2010

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  • ACTIVE INGREDIENT

    TRICLOSAN 0.115% (ANTIBACTERIAL)

  • USES

    TO HELP REDUCE BACTERIA ON SKIN

  • 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 A 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.
  • QUESTIONS/COMMENTS

    1-866-695-3030

  • PACKAGE FRONT AND BACK LABELS

    • 140.jpg
      1 GAL FRONT AND BACK LABELS
  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SOAP  WITH LIGHT MOISTURIZERS
    triclosan lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-140
    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:63148-140-503785 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33302/24/2010
    Labeler - APOLLO HEALTH AND BEAUTY CARE (201901209)