Label: GYNO-BETADINE- povidone iodine solution

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

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Drug Label Information

Updated March 20, 2019

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  • ACTIVE INGREDIENT

    POVIDONE-IODINE

  • PURPOSE

    Local treatment in the following cases: Candidate vaginitis, trichomonas vaginitis, non-specific and mixed infection, preoperative pre-operative treatment of obstetrics and gynecology, local cleaning and release

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Dilute 30 ml of water in about 1 liter of hot water and wash the inside and outside of vagina once or twice a day.Clean sterilizable vaginal cleaning, local cleaning, and deodorization once or twice a week.

  • WARNINGS

    Do not use
    in the eyes
    as a first aid antiseptic longer than one week
    on individuals who are allergic or sensitive to iodine
    over large areas of the body
    Keep out of reach of children.
    If swallowed, get medical help or contact a Poison Control Center right away.

  • INACTIVE INGREDIENT

    Water, etc.

  • DOSAGE & ADMINISTRATION

    For vaginal use only

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    GYNO-BETADINE 
    povidone iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72689-0041
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72689-0041-1180 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/21/2018
    Labeler - OASIS TRADING (689991468)
    Registrant - OASIS TRADING (689991468)
    Establishment
    NameAddressID/FEIBusiness Operations
    OASIS TRADING689991468manufacture(72689-0041) , relabel(72689-0041)
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