Otc - Active Ingredient
Povidone Iodine 7.5%
Aplicare Povidone-iodine Scrub Solution
FDA Label NDC 52380-2802
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 Scrub (NDC 52380-2802). 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, otc - do not use, otc - ask doctor, otc - keep out of reach of children, warnings, otc - questions, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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
For external use only
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
Dosage & Administration
Directions apply locally as needed
Otc - Stop Use
Stop use and ask a doctor if
• infection occurs
• redness, irritation, or swelling or pain persists or increases
Other Safety Information
Other information
• 0.75% titratable iodine
• latex free
• for hospital or professional use only
Inactive Ingredient
Inactive ingredients
• ammonium nonoxynol-4 sulfate
• citric acid
• disodium phosphate
• nonoxynol-9
• sodium hydroxide
• water
Package Label.Principal Display Panel
APLICARE
POVIDONE-IODINE SCRUB
ANTISEPTIC
NON-STERILE SOLUTION
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