FDA Label for Pvp-i Prep Pads Foil-foil

View Indications, Usage & Precautions

ACTIVE INGREDIENT:
PURPOSE:
USE:
WARNINGS:
OTC - DO NOT USE
OTC - ASK DOCTOR
OTC - STOP USE
OTC - KEEP OUT OF REACH OF CHILDREN
DIRECTIONS:
OTHER INFORMATION:
INACTIVE INGREDIENTS:
PRINCIPAL DISPLAY PANEL - PVP-I PREP PADS FOIL POUCH LABEL
PRINCIPAL DISPLAY PANEL - PVP-I PREP PADS FOIL 865-8000 CASE LABEL

Pvp-i Prep Pads Foil-foil 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.

Otc - Do Not Use

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 pad 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 Pads Foil Pouch Label

DUKAL™
CORPORATION

REF 882

STERILE

Povidone-Iodine
Prep Pad

For Professional and Hospital Use

Not Made with Natural Rubber Latex

1
/Pouch

Manufactured For:

DUKAL CORPORATION • (631) 656-3800

Ronkonkoma, NY 11779 • www.dukal.com

Made in China

Principal Display Panel - PVP-I Prep Pads Foil Pouch Label - pvp02 0000 01

Principal Display Panel - Pvp-I Prep Pads Foil 865-8000 Case Label

DUKAL™
CORPORATION

REF 882-8000

STERILE

POVIDONE-IODINE
PREP PADS

For Professional and Hospital Use

Not Made with Natural Rubber Latex

8000/Case

1/Pack

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