Proheal Povidone Iodine Solution
FDA Label NDC 86173-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Click Industries Llc for the product Proheal Povidone Iodine (NDC 86173-004). 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 drug facts, active ingredient, purpose, use:, warnings:, otc - keep out of reach of children, directions:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Povidone-iodine USP 10%
Purpose
Antiseptic
Use:
Antiseptic skin preparation.
Warnings:
1. Do not use if allergic to iodine.
2. For external use only.
3. Ask a doctor before use if injuries are
• deep or puncture wounds • serious burns
4. Stop use and ask a doctor if
• redness, irritation, swelling or pain persists or increases
• infection occurs
5. Do not use in eyes.
6. Avoid "pooling" beneath patient. Prolonged exposure to wet solution may cause skin irritation.
Otc - Keep Out Of Reach Of Children
7. Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.
Directions:
Apply locally as need.
Other Information:
• 1% available iodine
• latex free
• for hospital or professional use only
Inactive Ingredients:
Disodium hydrogen phosphate, Citric acid, Purified water.
Packaging
Ph Povidone Iodine Solution (86173004 3)
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