Otc - Active Ingredient
Povidone-iodine 10%
Aplicare Povidone-iodine Solution
FDA Label NDC 52380-2801
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 Products, Llc for the product Aplicare Povidone-iodine (NDC 52380-2801). 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, indications & usage, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antiseptic
Warnings
Warnings
Do not use if allergic to iodine
For external use only
Do not use in the eyes
Ask a doctor before use if injuries are
- deep or puncture wounds
- serious burns
- infection occurs redness
- redness, irritation, swelling or pain persists or increases
Stop use and ask a doctor if
Avoid pooling beneath patient. Prolonged exposure to wet solution may cause skin irritation.
Indications & Usage
• antiseptic skin preparation
• single use when used for patient preoperative skin preparation and/or preinjection indications
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.
Dosage & Administration
Directions apply locally as needed
Other Safety Information
Other information
• 1% titratable iodine
• latex free
• for hospital use only
Inactive Ingredient
• citric acid
• disodium phosphate
• nonoxynol-9
• sodium hydroxide
• water
Otc - Questions
Questions or comments?
1 800-760-3236 (Monday - Friday 8:30 AM - 5:00 PM EST)
Package Label.Principal Display Panel
APLICARE
POVIDONE-IODINE SOLUTION
ANTISEPTIC
NON-STERILE SOLUTION
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