Active Ingredients
Povidone-Iodine 10% w/v (equivalent to 1% titratable iodine)
Povidone Iodine Wipe
FDA Label NDC 34645-4011
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 Wipe (NDC 34645-4011). 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 active ingredients, purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
First Aid Antiseptic
Uses
First aid to help prevent infection in minorcuts, scraps, and burns
Warnings
For external use only.
Otc - Do Not Use
Do not apply to persons allergic to iodine. Do not use in the eyes.
Do not use if pouch is opened or damaged
Otc - Ask Doctor
Ask a doctor before use if injuries are deep wounds, puncture wounds, serious burns.
Otc - Keep Out Of Reach Of Children
- Keep out of reach of children
- If swallowed or gets in eyes, get medical help or contact a Poison Control Center right away.
Directions
- Clean the affected area
- Apply product on the area 1-3 times daily and discard
- May be covered with a sterile bandage when dry
Inactive Ingredients
Citric acid, Glycerin, Nonoxynol-10, Purified water, Sodium hydroxide
Package Label.Principal Display Panel
Image Of Pouch Label (Piw)
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