FDA Label for Aplicare Povidone-iodine

View Indications, Usage & Precautions

Aplicare Povidone-iodine Product Label

The following document was submitted to the FDA by the labeler of this product Aplicare, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



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


Otc - Purpose



Antiseptic

For temporary relief of minor itching and irritation


Warnings



Do not use if sensitive to iodine

For vaginal use only


Otc - 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

Otc - 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.



Otc - Questions




Questions or comments?

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



Package Label.Principal Display Panel



Povidone-iodine Douche


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