Label: BANG ER JIE HIGH-EFFICIENCY ANTI-BACTERIA MONOMER SILVER GEL FOR WOMEN- anti-bacteria monomer silver gel gel, dentifrice

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

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated September 23, 2013

If you are a consumer or patient please visit this version.

  • Active ingredient

    Silver content: 350 μg/g; 1050 μg/package

  • Purpose

    Anti-Bacteria

    Monomer silver gel is a highly active agent which significantly suppresses and eliminates Candida albicans, Escherichia coli, Staphylococcus aureus and Pseudomonas aeruginosa within and around the vagina, prevents and cures inflammation, accelerates the recovery of wounds and lesioned tissues regardless of vagina pH without affecting normal vaginal bacteria.

  • Indcations and usage

    Indication to bacterial vaginal diseases; vaginal candida infection; cervicitis; pruritus; abnormal vaginal discharge, or unpleasant smell due to vaginitis.

    Topical use: Apply on the affected area of vagina.

  • Dosage

    For bacterial vaginitis and candida infection, 1 package each day, for 7 consecutive days, or longer if serious.
    For cervicitis, 1 package each day, for 9 consecutive days, or longer if serious.

  • Warnings

    Contraindications:
    1, For external use only.

    2, Not for virgins.

    3, Do not use if allergic to silver.

    4, Pregnant women shall follow doctor advice.

    Notes:
    1, Pregnant women or women in period avoid application in deep part of vagina
    2, Do not use if package is broken; do not use with medicine that contains Vaseline, chlorine, iodine or hydrogen peroxide.
    3, This product is for external use only; do not take in. The gel may change in color, which is normal and has no impact on its effects.
    4, Keep away from clothes to prevent contamination. Sanitary napkin is recommended to absorb the fluid of gel from vagina.

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

  • Package label - Principal display panel

    Package Label.jpg.

    Package Lebel

    Container Lebel.jpg.

    Container Label

  • INACTIVE INGREDIENT

    Carbomer 934 content: 6 mg/g; 18 mg/package

    Water content: 293650 μg/g; 880950 μg/package

  • INGREDIENTS AND APPEARANCE
    BANG ER JIE HIGH-EFFICIENCY ANTI-BACTERIA MONOMER SILVER GEL FOR WOMEN 
    anti-bacteria monomer silver gel gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60659-0101
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Silver (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) Silver350 ug  in 3 g
    Inactive Ingredients
    Ingredient NameStrength
    Carbomer 934 (UNII: Z135WT9208) 6 mg  in 3 g
    Water (UNII: 059QF0KO0R) 293650 ug  in 3 g
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60659-0101-33 in 1 BOX; NCPDP billing unit = EA
    1NDC:60659-0101-13 g in 1 PACKAGE; NCPDP billing unit = EA
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/23/2013
    Labeler - Bang An Bao Medical Equipment Co., Ltd. (421323212)
    Registrant - Bang An Bao Medical Equipment Co., Ltd. (421323212)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bang An Bao Medical Equipment Co., Ltd.421323212fdf manufacture(60659-0101) , label(60659-0101) , manufacture(60659-0101)