Warnings
For external use only
Leader Povidone-iodine 10% Topical Solution Liquid
FDA Label NDC 70000-0060
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health for the product Leader Povidone-iodine 10% Topical Solution (NDC 70000-0060). 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 warnings, do not use, stop use and ask a doctor if, otc - keep out of reach of children, inactive ingredients, active ingredient, purpose, use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Do Not Use
- if allergic to iodine
- in the eyes
Stop Use And Ask A Doctor If
- irritation and redness develop
- condition persists for more than 72 hours
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Inactive Ingredients
Citric Acid Anhydrous, Disodium Phosphate Anhydrous, Glycerin, Polysorbate 80, Puried Water, Sodium Citrate USP
Active Ingredient
Povidone-iodine 10%
Purpose
Healthcare Antiseptic
Use
For preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection
Directions
Clean the area. Apply product to the operative site prior to surgery.
Other
Store at controlled room temperature 15°-30°C (59°-86°F).
Questions?
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