Label: APLICARE POVIDONE-IODINE- 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 April 26, 2010

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  • ACTIVE INGREDIENT

    Povidone-Iodine USP 10% (0.16% when diluted)

  • PURPOSE

    Antiseptic

    For temporary relief of minor itching and irritation

  • WARNINGS

    Do not use if sensitive to iodine

    For vaginal use only

  • STOP USE

     

    Stop use and ask a doctor if

    • symptoms persist for more than 7 days you have pain or tenderness in the lower part of the

      abdomen and pelvis
    • you have vaginal discharge or bleeding, chills, nausea, or fever 
    • your vaginal discharge is an unusual amount, color or  odor
    • you have frequent and painful urination
    • douching results in pain, soreness, swelling, redness,  itching, excessive dryness or irritation
  • ASK DOCTOR


    If pregnant or breast-feeding, ask a health professional before use 


  • DOSAGE & ADMINISTRATION

    Use twice weekly unless directed by a physician.  Add 1/2 fluid ounce (one tablespoonful) to 1 quart of lukewarm water.  For other uses consult a physician.


  • QUESTIONS


    Questions or comments?

    1 800 760-3236 (M-F 8:30 AM - 5:00 PM EST)


  • PRINCIPAL DISPLAY PANEL

    Povidone-iodine Douche

    Povidone-iodine douche

  • INGREDIENTS AND APPEARANCE
    APLICARE POVIDONE-IODINE  
    povidone-iodine douche
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-1730
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Povidone-iodine (UNII: 85H0HZU99M) (Iodine - UNII:9679TC07X4) Povidone-iodine10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Nonoxynol-10 (UNII: K7O76887AP)  
    Glycerin (UNII: PDC6A3C0OX)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Sodium Phosphate, Dibasic Anhydrous (UNII: 22ADO53M6F)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52380-1730-260 g in 1 BOTTLE
    2NDC:52380-1730-8240 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33309/01/1998
    Labeler - Aplicare, Inc. (107255002)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aplicare, Inc.058377631manufacture
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