Active Ingredient
Povidone-Iodine 10%
Povidone-iodine Gel Solution
FDA Label NDC 59050-556
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Changzhou Moakang Medical Products Co. Ltd for the product Povidone-iodine Gel Solution (NDC 59050-556). 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 ingredient, purpose, use, do not use, stop use and ask doctor if, keep out of reach of children, ask a doctor before use if injuries are, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Use
Antiseptic skin preparation
Do Not Use
- if allergic to Iodine
- in the eyes
Stop Use And Ask Doctor If
- redness, irritation, swelling or pain persists or increases
- infection occurs
Keep Out Of Reach Of Children
In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.
Avoid pooling beneath the patient
Ask A Doctor Before Use If Injuries Are
- deep puncture wounds
- serious burns
Directions
apply locally as needed
Other Information
- 1% titratable
- for hospital or professional use only
Inactive Ingredients
alkyl glucoside, anhydrous citric acid, glycerin, hydroxyethyl cellulose, nonoxynol-10, potassium iodide, sodium hydroxide, purified water
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