FDA Label for Povidone Iodine
View Indications, Usage & Precautions
Povidone Iodine Product Label
The following document was submitted to the FDA by the labeler of this product Trifecta Pharmaceuticals Usa Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Povidone Iodine USP 10%
w/w (available iodine 1%)
Purpose
First Aid Antiseptic
Uses
First Aid to help prevent infection in minor cuts, scrapes and burns.
Warnings
For external Use Only
Do not use
- in eyes
- over large areas of the body
- if you are allergic to any of the ingredients
Directions
- Clean the affected area
- apply a small amount of this product (equal to the surface area of a fingertip) to the area 1 to 3 times daily.
- may be covered with a sterile bandage
Ask Doctor Before Use If You Have
- deep or puncture wounds
- animal bites
- serious burns
Inactive Ingredients
Polyethylene glycol 400, Polyethylene glycol 4000
Questions?
Call 1-888-296-9067
Stop Use And Ask A Doctor If
- The condition persists or gets worse
- you need to use this product for more than 1 week
Storage Information
- Store at controlled room temperature 20° to 25°C (68°F to 77°F).
- close cap tightly after use.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222) right away.
Questions
1-888-296-9067
Other Information
Distributed By:
Trifecta Pharmaceuticals USA®
101 NE Third Ave. Ste 1500
Ft. Lauderdale, FL. 33301 USA
www.trifecta-pharma.com
* Please review the disclaimer below.