FDA Label for Pvp Iodine Prep Pad Medium And Large
View Indications, Usage & Precautions
Pvp Iodine Prep Pad Medium And Large Product Label
The following document was submitted to the FDA by the labeler of this product Professional Disposables International, Inc.. 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 (equivalent to 1.0% titratable iodine)
Purpose
Antiseptic
Uses
- A broad spectrum antiseptic for topical application for preparation of the skin prior to surgery.
- First Aid antiseptic to help prevent the risk of skin infection in minor cut, scrapes and burns.
Warnings
For external use only
Do not use
- in the eyes, nose or mouth
- on individuals who are allergic or sensitive to iodine
- over large areas of the body
- as a first aid antiseptic longer than one week unless directed by a doctor
- Deep or puncture wounds
- animal bites
- serious burns
- if you are pregnant
Discontinue use if irritation and redness develop. If condition persist for more than 72 hours or gets worse, consult a healthcare provider
Consult a healthcare provier in case of
Avoid pooling
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
For the preparation of the skin prior to surgery
- clean the treatment area
- remove applicator
- apply to the operative site prior to surgery
- allow to dry
- clean the treatment area
- apply a small amount of this product on the treatment area 1-3 times daily as directed
- may be covered with a sterile bandage
- if bandaged, let dry before applying bandage to prevent possible irritation
For use as a first aid antiseptic
Other Information
- Store at room temperature
- Avoid excessive heat
Inactive Ingredients
Purified Water, Sodium Hydroxide
Questions?
Professional Disposables International, Inc.
Orangeburg, NY 10962-1376
USA - 1-800-999-6423
www.pdipdi.com Made in USA
Principal Display Panel And Labels
Packet 1 swabstick
Box 1 swabstick
Packet 3 swabsticks
Box 3 swabsticks
Packet med
Box med
Packet large
Box large
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