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 Major Pharmaceuticals. 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
Active Ingredient Purpose
Povidone Iodine 10% v/v Antiseptic
Uses
- First aid antiseptic to help prevent infection in minor cuts, scrapes and burns.
- Healthcare antiseptic for preparation of the skin prior to surgery.
- Antiseptic cleanser for preparation of skin prior to an infection.
Warnings
- FOR EXTERNAL USE ONLY
Do Not Use
- As a first aid antiseptic for more than 1 week unless directed by a doctor.
- In the eyes.
- Over large areas of the body.
- On individuals who are allergic or sensitive to iodine.
Ask A Doctor Before Use If You Have
- Deep puncture wounds
- Animal bites
- Serious burns
Stop Use
- If irritation and redness develop
- If condition persists for more than 72 hours, consult a physician.
Keep Out Of Reach Of Children
Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center.
Directions
As a first aid antiseptic
- clean affected area
- apply a small amount of this product to the area1 to 3 times daily
- may be covered with a sterile bandage, if bandaged let dry.
- clean area
- apply to operative site prior to surgery using the applicator
For preoperative patient skin preparation
Inactive Ingredient
- citric acid
- glycerin
- sodium citrate
- tween 80
- disodium phosphate
- purified Water
Principal Display Panel
NDC 0904-1103-09
Distributed by
Major Pharmaceuticals
Livonia, MI 48150 USA
Povidine Iodine Topical 10% Solution
8 Fl Oz. (236 mL)
* Please review the disclaimer below.