Label: RECURO VAGINAL- povidone iodine douche

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 25, 2010

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  • 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

  • PRINCIPAL DISPLAY PANEL

    Recuro Vaginal Douche1

  • PRINCIPAL DISPLAY PANEL

    Recuro Vaginal Douche2

  • INGREDIENTS AND APPEARANCE
    RECURO VAGINAL  
    povidone iodine douche
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51670-100
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) POVIDONE-IODINE0.30 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PHOSPHATE ION (UNII: NK08V8K8HR)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51670-100-011 in 1 BOX
    110 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/25/2010
    Labeler - IONA PHARMACY (962591116)
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