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RECURO VAGINAL (IONA PHARMACY)

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DOUCHE 1 BOTTLE in 1 BOX (51670-100-01) > 10 mL in 1 BOTTLE Label Information

Complete RECURO VAGINAL Information

  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredient                              Purpose

    Povidone-Iodine 0.30%..............Vaginal Douche


  • PURPOSE

    Purpose

    Vaginal Douche


  • INDICATIONS & USAGE

    Uses

    For relief of minor vaginal irritation and itching

    For relief of minor vaginal soreness.


  • WARNINGS

    Warnings

    Ask a doctor before use if you have

    Kidney disfunction

    Thyroid gland dysfunction


  • DO NOT USE

    Do not use

    orally

    if you are sensitive to iodine


  • STOP USE

    Stop use and ask a doctor if

    minor irritation has not improved after 1 week of use

    symptoms continue or redness, swelling or pain develop


  • PREGNANCY OR BREAST FEEDING

    If pregnant or breasts feeding, ask a health professional before use.


  • 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.


  • DOSAGE & ADMINISTRATION

    Directions. Use as a douche as needed, except under the advice and supervision of a physician.


  • DESCRIPTION

    Other Information

    Store below 98F/37C avoid direct heat and sunlight


  • INACTIVE INGREDIENT


    Inactive Ingredients
    citric acid, disodium phosphate, water

  • PRINCIPAL DISPLAY PANEL

    NDC 51670-100-01

    This unit not relabeled for retail sale.

    Recuro

    Vaginal Douche

    Liquid Solution



    Vaginal Drug Product- For minor irritations



    DOES NOT PREVENT PREGNANCY



    keep this and all drugs out of the reach of children.



    net 0.33 fl oz (10ml)

    **do not use if carton is open or damaged.**

    To report a serious adverse event contact 1 (703) 646-8867

    Expiration date         Lot Number



    Distributed by Iona Pharmacy LLC

    11654 Plaza America Drive Suite 777

    Reston, Virginia 20190 USA



    Iona Pharmacy LLC

    www.iona pharmacy .com

    Tel: +1-703-928-8552    Fax: 1-703-773-6921



    Manufactured by:

    Chuzhou Iris Family Product Co., Ltd.

    No. 118, Ze-Wei Southern Road

    Chuzhou, Anhui Province, China 239000

    Email: info@ionapharmacy.com

    Product of China


  • INGREDIENTS AND APPEARANCE
    RECURO VAGINAL  
    povidone iodine douche
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51670-100
    Route of Administration VAGINAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) POVIDONE-IODINE 0.30 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PHOSPHATE ION (UNII: NK08V8K8HR)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51670-100-01 1 in 1 BOX
    1 10 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 10/25/2010
    Labeler - IONA PHARMACY (962591116)