Drug Facts
Active ingredient
Povidone-iodine, 10% (1% available iodine)
Povidone-iodine 10% Solution
FDA Label NDC 69452-483
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bionpharma Inc. for the product Povidone-iodine 10% (NDC 69452-483). 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, purpose, uses, warnings, do not use, ask a doctor before use, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
First aid antiseptic
Uses
first aid to help prevent infection in minor • cuts • scrapes • burns
Warnings
For exmrnal use only
Do Not Use
• in the eyes • over large areas of the body
Ask A Doctor Before Use
in case of deep or puncture wounds, animal bites, or serious burns
Stop Use And Ask A Doctor If
• the condition persists or gets worse • you need to use this product for more than 1 week
Keep Out Of Reach Of Children.
if swallowed, get medical help or contact a Poison Control Center right away.
Directions
• clean the affected area
• apply a small amount of product to the area 1 to 3 times daily
• may be covered with a sterile bandage • it bandaged, let dry first
Other Information
• store at 20°-25°C (68°-77°F)
Inactive Ingredients
citric acid, dibasic sodium phosphate, glycerin, nonoxynol-9, purified water and sodium hydroxide
Questions Or Comments?
1-888-235-2466
Other
Manufactured for:
Bionpharma Inc.,
Princeton, NJ 08540
**This product is not manufactured or dislributed by the owners of Betadine ®
L0001034
R0425
8 Fl Oz (237 Ml) Bottle
** compare to the active ingredient in Betadine®
a+ health TM
first aid
antiseptic
povidone-
iodine 10%
topical solution USP
• helps prevent infection
in minor cuts, scrapes & burns
8 fl oz (237 mL)
Bottle-label (Bottle Label)
* Please review the disclaimer below.
