FDA Label for Povidine Iodine
View Indications, Usage & Precautions
Povidine Iodine Product Label
The following document was submitted to the FDA by the labeler of this product Dynarex Corporation. 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.
Otc - Active Ingredient
Section Text
Active Ingredient Purpose
Povidone Iodine 10% w/v (9.85% w/w) Antiseptic
Purpose
- First aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns.
- For preparation of the skin prior to surgery.
- Helps reduce bacteria that can potentially cause skin infections.
Do Not Use:
Section Text
- As a first aid antiseptic for more than 1 week.
- In the eyes.
- Over large areas of the body.
Warnings
FOR EXTERNAL USE ONLY
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:
Tear at notch, remove applicator, use only once.
As a first aid antiseptic
- clean affected area
- apply 1 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
Usage
- As a first aid antiseptic and preparation of skin prior to surgery.
Other Information:
Store at room temperature.
Avoid excessive heat
Inactive Ingredients
Citric acid, glycerin, poysorbate 80, sodium citrate USP, sodium phosphate dibasic, water
Principal Display Panel
Principal Display Panel
* Please review the disclaimer below.