Label: GYNO-BETADINE- povidone iodine suppository

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated March 21, 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

    Put 200 mg deep into the vagina once a day. It is advisable to insert it in the evening before bedtime. To increase or decrease appropriately according to age and symptoms.

  • 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

    POLYETHYLENE GLYCOL 1540

  • DOSAGE & ADMINISTRATION

    For vaginal use only

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    GYNO-BETADINE 
    povidone iodine suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72689-0042
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72689-0042-110 in 1 BLISTER PACK; 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(72689-0042) , relabel(72689-0042)
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