Label: FEMALE INTIMATE HYGIENE ANTIBACTERIAL GELS- benzalkonium bromide gel

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

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Drug Label Information

Updated June 7, 2021

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  • SPL UNCLASSIFIED SECTION

    Female Intimate Hygiene Antibacterial Gels

  • Active Ingredient(s)

    Benzalkonium bromide 0.10% w/w. Purpose: Antibiotic

  • Purpose

    Antibiotic, Female Intimate Hygiene Antibacterial Gels

  • Use

    for vagina to inhibit Staphylococcus aureus, Escherichia coli and Candida albicans.This product is not a substitute for medicines.

  • Warnings

    For external use only
    Disposable, do not reuse it

  • Do not use

    • during menstruation, pregnancy, or breastfeeding
  • WHEN USING

    do not get into eyes
    if contact occurs, rinse eyes throughly with water

  • 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

    • Wash hands and clean the vulva
    • Remove the front cover of the gel and insert the removed front cover into the rear end of the gel tube as a push rod
    • Lie on your back and push the gel into the vagina with the gel pusher
    • Take out the gel pusher, and lie still for three minutes.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Sophora Flavescens Root Extract, Averrhoa Carambola Fruit
    Extract, Glycine Max (Soybean) Seed Extract, Pyrus Pyrifolia Fruit Extract

  • Package Label - Principal Display Panel

    21

  • INGREDIENTS AND APPEARANCE
    FEMALE INTIMATE HYGIENE ANTIBACTERIAL GELS 
    benzalkonium bromide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81983-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM BROMIDE (UNII: 151T1GQ42D) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM BROMIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    NASHIPATI (UNII: SHY4TJD066)  
    SOPHORA FLAVESCENS WHOLE (UNII: X8KX602M5L)  
    STAR FRUIT (UNII: G00N2E9394)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81983-101-0210 in 1 BOX06/08/2021
    1NDC:81983-101-013.5 g in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/08/2021
    Labeler - ShenZhen MengTi Biotechnology Co.Ltd (705839690)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yunnan Baifeng Pharmaceutical Co. Ltd731098614manufacture(81983-101)
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