Active Ingredient
Povidone-Iodine 5%
(0.5% available iodine)
Povidone Iodine Liquid
FDA Label NDC 0395-9129
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Humco Holding Group, Inc. for the product Povidone Iodine (NDC 0395-9129). 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, warnings, do not use:, ask a doctor before use if you have:, stop and ask a doctor if:, keep out of reach of children, other information, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings
For external use only.
Do Not Use:
- In the eyes
- Over large areas of the body
- If you are allergic to povidone-iodine or any other ingredients in this preparation
Ask A Doctor Before Use If You Have:
- Deep or puncture wounds
- Serious burns
- Animal bites
Stop And Ask A Doctor If:
- The condition persists or gets worse
- You need to use this product for more that 1 week
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Other Information
Store at 25°C (77°F); Excursions permitted between 15-30°C (59-86°F). Do not freeze.
Inactive Ingredients:
citric acid, disodium phosphate, glycerin, poloxamer 407, potassium iodata, purified water, sodium hydroxide.
Directions:
- Clean the affected area
- Spray a small amount of product on the area 1 to 3 times daily
- May be covered with a sterile bandage
- If bandaged, let dry first
Uses
First aid to help prevent infection in minor
- cuts
- scrapes
- burns
Purpose
Antiseptic
Other
Drug Facts
* Please review the disclaimer below.
