Label: ZEDOARY OILS FEMININE ANTIBACTERIAL GELS- chlorhexidine diacetate gel

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated April 20, 2021

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  • SPL UNCLASSIFIED SECTION

    ZEDOARY OIL FEMININE ANTIBACTERIAL GEL

  • Active Ingredient(s)

    CHLORHEXIDINE DIACETATE 0.09g/100g

  • Purpose

    BACTERIOSTATIC

  • Use

    Uses for female daily intimate internal & external cleaning and hygiene care.

  • Warnings

    Disposable product. Please do not use if the package is broken.

    This product is for external use only, not edible.

    Avoid contact with eyes

    This product cannot be used for STD prevention in sexual activity.

    Women who are in menstrual, gestational or perinatal periods should be used with extreme caution.

  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    1.Take a supine position, and support the hip with a cushion. Remove the socket at the top of the injector and use it as the plunger rod. Slowly insert the gel injector containing antibacterial gel into the deep area of vagina. Deliver the gel into the vagina by pushing the plunger.
    2.If there is discomfort in the intimate area, squeeze a little of the gel and apply onto the area, then gently rub for a while.
    3.While in use, it’s normal to see vaginal discharge, so it’s recommended to use panty liners meanwhile.
    4.Better effect can be obtained if FUYANJIE WASH is used before applying this product.

  • Other information

    This product can sterilize staphylococcus aureus, Escherichia coli, and Candida albicans.

    Keep in sealed container, and place in a cool dry place.

  • Inactive ingredients

    SOPHORA FLAVESCENS
    STEMONA TUBEROSA
    FRUCTUS CNIDII
    ZEDOARY OIL
    CARBOMER
    PURIFIED WATER

  • Package Label - Principal Display Panel

    123

  • INGREDIENTS AND APPEARANCE
    ZEDOARY OILS FEMININE ANTIBACTERIAL GELS 
    chlorhexidine diacetate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81615-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE ACETATE0.09 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ZEDOARY OIL (UNII: QPP5U30FSD)  
    OSTHOL (UNII: XH1TI1759C)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    STEMONA TUBEROSA ROOT (UNII: 7S9328671Z)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81615-002-027 in 1 BOX03/16/2021
    1NDC:81615-002-015 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:81615-002-0410 in 1 BOX03/16/2021
    2NDC:81615-002-032 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:81615-002-0610 in 1 BOX03/16/2021
    3NDC:81615-002-053 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/16/2021
    Labeler - Jiangxi Renhetang pharmaceutical chain Co., Ltd. (410551226)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiangxi Kangmei medical and Health Products Co., Ltd528118770manufacture(81615-002)