Label: FU ER JIE- 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 March 19, 2015

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  • Active Ingredient

    Triclosan    0.12%  

  • Purpose

    Antimicrobial

  • Uses

    For Vaginal Cleansing. Kills Germs.

  • Warning

    Keep out of reach of children.

    Wash and douche with water.

  • WARNINGS

    Discontinue use if any burning, itching, or irritation of the vagina occurs during use.

    During pregnancy.

    Do not use during breast feeding.

    Do not use during period and 4 days after period ends.

  • When using this product

    Avoid contact with the eyes.

    Use caution if prone to allergic reactions.

  • Directions

    Vulva clean: directly apply the right amount of this product to vulva, add some water and gently knead until foaming, later rinse off with clear water.

    Vagina cleaning: fill the injector with this product, and slowly insert it deep in vagina to release liquid.

  • Other Information

    Gynecologic daily care lotion

    Sealed and kept in shade.

  • Inactive Ingredients

    SOPHORA FLAVESCENS ROOT, STEMONA TUBEROSA ROOT, PHELLODENDRON CHINENSIS BARK

  • Questions or Comments?

    E-mail: info@bjwellspring.com

  • Manufactured by

    Henan Lingrui Pharmaceutical Co.; Ltd.

    232 Xiang Yang Road, Xin County, Henan, China

    Beijing Lingrui Wellspring Imp. & Exp. Co.; Ltd.

    Overseas Exclusive Distribution

  • Drug Facts

    image description

  • INGREDIENTS AND APPEARANCE
    FU ER JIE 
    triclosan lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42217-208
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.12 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    STEMONA TUBEROSA ROOT (UNII: 7S9328671Z)  
    PHELLODENDRON CHINENSIS BARK (UNII: 2866QMZ434)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42217-208-021 in 1 BOX
    1100 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/02/2010
    Labeler - Henan Lingrui Pharmaceutical Co Ltd (530021062)
    Registrant - Henan Lingrui Pharmaceutical Co Ltd (530021062)
    Establishment
    NameAddressID/FEIBusiness Operations
    Henan Lingrui Pharmaceutical Co Ltd530021062manufacture(42217-208)
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