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 Pss World Medical, 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/v

(equipvalent to 1% titratable iodine)


Purpose



Antiseptic


Uses



  • Health-care antisptic for preparation of the skin prior to surgery
  • First aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes, and burns

Warnings



For external use only.


Do Not Use



Do not use or apply

  • in the eyes
  • on individuals who are allergic or sensitive to iodine
  • over large areas of the body
  • as a first aid antiseptic longer than 1 week unless directed by a doctor

Stop Use And Consult A Doctor



Discontinue use if irritation and redness develop.

Consult a doctor in case of

  • deep or puncture wounds
  • animal bites
  • serious burns
  • Stop use and cosult a doctor if the condition persists or gets worse.


Keep Out Of Reach Of Children



Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.


Directions



For preparation of the skin prior to surgery

Clean the affected area, remove swab by stick, apply to the operative site prior to surgery.

For use as a first aid antiseptic

Clean the affected area, apply a small amount of this product on the area 1-3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.


Other Information



Store at room temperature: 15-30C (59-86F)


Inactive Ingredients



Citrict Acid, Glycerin, Nonoxynol-8, Purified Water, Sodium Hydroxide


Questions



Questions about Select? 800-777-4908

Manufactured for PSS World Medical, Inc.

4345 Southpoint Blvd., Jacksonville, FL 32216

Made in China


Package Label



986 Each

9986 Box

68345-863-01

1 each/pouch

50 pouches/box

68345-863-03

3 each/pouch

25 pouches/box

PPovidone Iodine, USP Swabsticks

AAntiseptic Germicide Sterile

  • Topical pre-surgical and first aid antiseptic swabstick
  • For hospital and professional use only
  • Single use only. Sterile unless package is opened or damaged.


* Please review the disclaimer below.