Active Ingredient
Povidone Iodine IP 5% w/v.
Aurodone Povidone Iodine 5 % Opthalmic Solution
FDA Label NDC 16030-601
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aurolab for the product Aurodone Povidone Iodine 5 % Opthalmic Solution (NDC 16030-601). 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, inactive ingredient, use, questions, keep out of reach of children, stop use, do not use, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
- Citric acid
- Disodium hydrogen O- phosphate, Potassium iodate
- Glycerin
- Purified water
Use
- For preparation of the skin prior to surgery
- Helps reduce bacteria that potentially can
cause skin infection
Questions
Call. 1-800-103-7321,
E-mail : [email protected]
Web : www.aurolab.com
Keep Out Of Reach Of Children
If swallowed get medical help or contact a Poison Control Center right away.
Stop Use
Irritation, sensitization, or allergic reaction
occurs and lasts for 72 hours. These may
be signs of a serious condition.
Do Not Use
- If you are allergic to povidone-iodine or
any other ingredients in this preparation
In the eyes
Warnings
For External use only
Indiacations And Usage
Prolonged exposure to wet solution may
cause irritation or, rarely, severe skin
reactions
In pre-operative prepping, avoid “pooling”
beneath the patient
Purpose
Antiseptic
Dose
- Clean the area and apply product to the operative site prior to surgery.
- The solution can be used to irrigate the cornea and conjunctiva with a sterile bulb syringe prior to surgery.
- After the solution has been left in contact for two minutes flush the residual prep solution using a sterile saline solution.
* Please review the disclaimer below.
