FDA Label for Aplicare Povidone-iodine Paint
View Indications, Usage & Precautions
Aplicare Povidone-iodine Paint 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
- in the eyes
- deep wounds
- puncture wounds
- serious burns
- redness, irritation, swelling or pain persists or increases
- infection occurs
For external use only
Ask a doctor before use if injuries are
Stop use and ask a doctor if
Avoid pooling beneath patient. Prolonged exposure to wet solution may cause skin irritation.
Avoid excessive heat. Store at room temperature.
Indications & Usage
Directions use sponge sticks to prep desired area
Other Safety Information
Other information
• 1% titratable iodine
• latex free
• for hospital or professional use only
Inactive Ingredient
Inactive Ingredients
• citric acid
• disodium phosphate
• nonoxynol-9
• sodium hydroxide
• water
Otc - Questions
For questions, comments, or to report serious side effects:
800-760-3236
Monday-Friday
8:30 a.m.-5:00 p.m. EST
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
Antiseptic skin preparation
Package Label.Principal Display Panel
APLICARE
POVIDONE-IODINE PAINT
SPONGE STICKS
ANTISEPTIC
STERILE Solution
* Please review the disclaimer below.
