FDA Label for Aplicare Povidone-iodine Scrub
View Indications, Usage & Precautions
Aplicare Povidone-iodine Scrub 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 7.5%
Otc - Purpose
Antiseptic
Otc - Do Not Use
Do not use if allergic to iodine
Do not use in eyes
Otc - Ask Doctor
Ask a doctor before use if injuries are
• deep or puncture wounds
• serious burns
Stop use and ask a doctor if
• infection occurs
• redness, irritation, swelling or pain persists or increases
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.
Warnings
Warnings
Do not use if allergic to iodine
For external use only
Do not use in eyes
Avoid "pooling" beneath patient. Prolonged exposure to wet solution may cause skin irritation.
Otc - Questions
Questions or comments?
1 800 760-3236 (Monday - Friday 8:30 AM - 5:00 PM EST)
Indications & Usage
Use
• antiseptic skin preparation
• single use when used for patient preoperative skin preparation and/or preinjection indications
Inactive Ingredient
Inactive Ingredients
• ammonium nonoxynol-4 sulfate
• citric acid
• disodium phosphate
• nonoxynol-9
• sodium hydroxide
• water
Dosage & Administration
Directions
apply locally as needed
Other Safety Information
Other information
• 0.75% titratable iodine
• latex free
• for hospital or professional use only
Package Label.Principal Display Panel
APLICARE POVIDONE-IODINE SCRUB ANTISEPTIC
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