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 Products, Llc. 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%
Otc - Purpose
Antiseptic
Warnings
Warnings
Do not use if allergic to iodine
Do not use in eyes
For external use only
Avoid pooling beneath patient
Ask a doctor before use if injuries are
- deep or puncture wounds
- serious burns
- redness, irritation, swelling or pain persists or increases
Stop use and ask a doctor if
Indications & Usage
Use
• antiseptic skin preparation
• single use when used for patient preoperative skin preparation and/or preinjection indications.
Dosage & Administration
Directions apply locally as needed
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.
Other Safety Information
Other information
• 1% titratable iodine
• latex free
• for hospital or professional 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 SOLUTION
ANTISEPTIC
NON-STERILE SOLUTION
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