FDA Label for Pvp-iodine Swabstick Threes

View Indications, Usage & Precautions

Pvp-iodine Swabstick Threes Product Label

The following document was submitted to the FDA by the labeler of this product Dukal 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%


Purpose:



Antiseptic


Use:



For preparation prior to surgery. Helps to reduce bacteria that can potentially cause skin infection.


Warnings:



For external use only.

  • Do not apply to persons allergic to iodine. Do not use in the eyes.

Otc - Ask Doctor



  • Ask a doctor before use if injuries are deep wounds, puncture wounds, serious burns.

Otc - Stop Use



  • Stop use and ask a doctor if irritation and redness develop, condition persists for more than 72 hours, infection occurs.
  • Avoid pooling beneath the patient. Prolonged exposure to wet solution may cause skin irritation.

Otc - Keep Out Of Reach Of Children



  • Keep out of reach of children
  • If swallowed or gets in eyes, get medical help or contact a Poison Control Center right away.

Directions:



Clean the area. Apply product to the operative site prior to surgery using sponge sticks to prep desired area.


Other Information:



1% titratable iodine, for hospital or professional use only.

Store at ambient temperatures.


Inactive Ingredients:



Citric Acid, Glycerin, Sodium Hydroxide, Potassium Iodide, Alkyl Glucoside, Nonoxynol-10, Hydroxyethyl Cellulose and Purified Water.


Principal Display Panel - Pvp-I Prep Swabstick Sterile 883-500 Pouch Label



DUKAL™
CORPORATION

REF 883

STERILE

POVIDONE-IODINE
SWABSTICKS

For Professional and Hospital Use

Not Made with Natural Rubber Latex

3
/Pouch

2

Manufactured For:

DUKAL CORPORATION • (631) 656-3800

Ronkonkoma, NY 11779 • www.dukal.com

Made in China

D02221801


Principal Display Panel - Pvp-I Prep Swabstick Sterile 883-500 Case Label



DUKAL™
CORPORATION

REF 883-500

STERILE

POVIDONE-IODINE
SWABSTICKS

For Professional and Hospital Use

Not Made with Natural Rubber Latex

500/Case

3/Pack

2

Manufactured For: DUKAL CORPORATION • (631) 656-3800

Ronkonkoma, NY 11779 • www.dukal.com

Made in China, Hecho en China, Fabriqué en Chine

(01) 40665973024989


Principal Display Panel - Pvp-I Prep Swabstick Sterile 884-1000 Pouch Label



DUKAL™
CORPORATION

REF 884

STERILE

POVIDONE
IODINE
SWABSTICK

For Professional and Hospital Use

Not Made with Natural Rubber Latex

1
/Pouch

2

Manufactured For:

DUKAL CORPORATION • (631) 656-3800

Ronkonkoma, NY 11779 • www.dukal.com

Made in China

D02231801


Principal Display Panel - Pvp-I Prep Swabstick Sterile 884-1000 Case Label



DUKAL™
CORPORATION

REF 884-1000

STERILE

POVIDONE-IODINE
SWABSTICKS

For Professional and Hospital Use

Not Made with Natural Rubber Latex

1000/Case

1/Pack

2

Manufactured For: DUKAL CORPORATION • (631) 656-3800

Ronkonkoma, NY 11779 • www.dukal.com

Made in China, Hecho en China, Fabriqué en Chine

(01) 40665973025009


Principal Display Panel - Pvp-I Prep Swabsticks Sterile 883 Carton Label



DUKAL™
CORPORATION

REF 883

STERILE

POVIDONE-IODINE
SWABSTICKS

For Professional and Hospital Use

Not Made with Natural Rubber Latex

25

/box

3/pouch

2

Manufactured For: DUKAL CORPORATION • (631) 656-3800

Ronkonkoma, NY 11779 • www.dukal.com

Made in China, Hecho en China, Fabriqué en Chine

D02221802


Principal Display Panel - Pvp-I Prep Swabstick Sterile 883 Carton Case Label



DUKAL™
CORPORATION

REF 883

STERILE

POVIDONE-IODINE
SWABSTICKS

For Professional and Hospital Use

Not Made with Natural Rubber Latex

10 Boxes/Case

25 Packs/Box

3/Pack

2

Manufactured For: DUKAL CORPORATION • (631) 656-3800

Ronkonkoma, NY 11779 • www.dukal.com

Made in China, Hecho en China, Fabriqué en Chine

(01) 30665973024982


* Please review the disclaimer below.