Label: HYDROGEL ESSENCE ANTIMICROBIAL VIRGINAL GEL.- chlorhexidine acetate gel

  • NDC Code(s): 84642-001-01
  • Packager: Guangdong Amoreneg Medicine Research and Development Co., LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated August 15, 2024

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  • Active ingredient

    Chlorhexidine acetate 0.15%

  • Purpose

    Vaginal Antiseptic

  • Use

    Inhibitory microorganisms: Escherichia coli, Staphylococcus aureus, Candida albican

  • Warnings

    ■ For vaginal use only;

    ■ Do not take orally;

    ■ Avoid co-use with antagonistic drugs;

    ■ It shall not be used for the prevention of sexually transmitted diseases during sexual life.

    Stop use and ask a doctor

    if you get a rash or hives, abdominal pain,fever, chills, nausea, vomiting, or a foul-smelling vaginal discharge.

    If pregnant or nreast-feeding

    ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Aduits and children 12 years of age and over: Thoroughly clean the vulva.Take one tube of the product and remove the cap from the gel applicator. Lie flat on your back. Gently insert the applicator into the vagina and push the hydrogel inside. Remain lying still for 2 minutes to allow the hydrogel to set and transition from liquid to gel format at body temperature.Children under 12 years of age: ask a doctor

  • Storage

    Store the product at room temperature for convenience.
    For optimail results, store between 4°C and 20°C

  • Inactive ingredients

    Chitosan, Poloxamer 407 and Zinc Chloride

  • label＆pack

    84642

  • INGREDIENTS AND APPEARANCE
    HYDROGEL ESSENCE ANTIMICROBIAL VIRGINAL GEL. 
    chlorhexidine acetate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84642-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE ACETATE5.25 mg  in 3.5 g
    Inactive Ingredients
    Ingredient NameStrength
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    POLIGLUSAM (UNII: 82LKS4QV2Y)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84642-001-013.5 g in 1 TUBE; Type 0: Not a Combination Product08/15/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/15/2024
    Labeler - Guangdong Amoreneg Medicine Research and Development Co., LTD (620842669)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangdong Amoreneg Medicine Research and Development Co., LTD620842669manufacture(84642-001)
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