Label: PLANT HERB BASED BACTERIOSTATIC FEMININE WASH- chlorhexidine diacetate liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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

    PLANT & HERB BASED BACTERIOSTATIC FEMININE WASH

  • Active Ingredient(s)

    CHLORHEXIDINE DIACETATE 0.10g/100mL

  • Purpose

    BACTERIOSTATIC

  • Use

    Uses for intimate cleaning, such as male/female daily hygiene care and female intimate douches.

  • Warnings

    This product is for external use only, not edible.

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

    Sediment after storage is completely natural. It does not affect usage effect.

    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. For intimate cleaning and daily hygiene care: take proper amount of the wash to douche the area that needs cleaning and hygiene care.
    2. For intimate douches: take proper amount of the wash and pour it into a douche bottle, insert in the vagina, then squeeze the bottle to douche

  • Other information

    This product is mainly effective in inhibiting Escherichia coli growth, with inhibitory effect to staphylococcus aureus and Candida albicans as well.

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

  • Inactive ingredients

    SOPHORA FLAVESCENS
    STEMONA TUBEROSA
    FRUCTUS CNIDII
    CORTEX PHELLODENDRI
    PURIFIED WATER

  • Package Label - Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    PLANT HERB BASED BACTERIOSTATIC FEMININE WASH 
    chlorhexidine diacetate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81615-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE ACETATE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    OSTHOL (UNII: XH1TI1759C)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    STEMONA TUBEROSA ROOT (UNII: 7S9328671Z)  
    WATER (UNII: 059QF0KO0R)  
    PHELLODENDRON CHINENSE WHOLE (UNII: QKA3ZK8IIE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81615-006-01380 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/2021
    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(81615-006)