Otc - Active Ingredient
Povidone-Iodine USP 10% (0.16% when diluted)
Aplicare Povidone-iodine
FDA Label NDC 52380-1730
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aplicare, Inc. for the product Aplicare Povidone-iodine (NDC 52380-1730). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - stop use, otc - ask doctor, dosage & administration, otc - questions, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Povidone-iodine Douche (Lbl82236)
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