Otc - Active Ingredient
Active Ingredients
Povidone Iodine 10%
Povidone Iodine Surgical Scrub
FDA Label NDC 34645-4021
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jianerkang Medical Co., Ltd for the product Povidone Iodine Surgical Scrub (NDC 34645-4021). 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, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antiseptic
Indications & Usage
Use
For cleansing hands and arms prior to surgery
Warnings
Warnings
For external use only
Do not use in the eyes
Otc - Stop Use
Stop Use and ask a doctor if
Skin shows symptoms of irritation, sensitivity, redness, pain or swelling
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
If swallowed, get medical help or contact Poison Control Center right away
Dosage & Administration
Directions
Wet hands and forearms with water
Clean under nails with nail cleaner
Scrub for 3 minutes with the impregnated brush
Pay close attention to the nails, cuticles, and interdigital spaces
Rinse thoroughly with running water
Repeat
Storage And Handling
Other Information
Store at room temperature
Avoid excessive heat above 40 o C (104 oF)
Protect from freezing
Latex free
Inactive Ingredient
Inactive Ingredients
Hydroxyethylcellulose, Nonoxynol - 10, Purified Water
Package Label
Pouch Label (Pouch)
* Please review the disclaimer below.
