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 10%
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
* Please review the disclaimer below.