65517-0034

Drug Facts

Composition & Product

Active Ingredients

Iodine (1 g)

Inactive Ingredients

Glycerin Hydroxyethyl Cellulose (2000 Mpa.s At 1%) Nonoxynol-10 Anhydrous Citric Acid Sodium Hydroxide Water C12-20 Alkyl Glucoside Potassium Iodide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2018-01-31

Medication Information

Purpose

Antiseptic

Description

Povidone Iodine USP 10%

Use:

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

Section 50565-1

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

Section 50566-9

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.

Section 50569-3

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

Section 50570-1

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

Purpose:

Antiseptic

Warnings:

For external use only.

Directions:

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

Active Ingredient:

Povidone Iodine USP 10%

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

Povidone-Iodine Prep Pad

Sterile

Antiseptic

For Professional and Hospital Use

Not made with natura rubber latex

Sterile unless package is damaged or opened.

Manufactured For: Dukal, LLC

1(800)243-0741 / Ronkonkoma, NY 11779 / dukal.com

Made in China

Dukal is a trademark registered in the

US Patent & Trademark Office by Dukal, LLC

1 Per Pouch - 2 - NDC 6551-0034-1 - REF 882

Principal Display Panel Pvp I Prep Pads Paper Pouch Label

Dukal

Povidone-Iodine Prep Pad

Sterile

Antiseptic

For Professional and Hospital Use

Not made with natura rubber latex

Sterile unless package is damaged or opened.

Manufactured For: Dukal, LLC

1(800)243-0741 / Ronkonkoma, NY 11779 / dukal.com

Made in China

Dukal is a trademark registered in the

US Patent & Trademark Office by Dukal, LLC Rev1

1 Per Pouch - 2 - NDC 6551-0034-2 - REF 889

Structured Label Content

Use:

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

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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.

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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

Purpose:

Antiseptic

Warnings:

For external use only.

Directions:

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

Active Ingredient:

Povidone Iodine USP 10%

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 (Principal Display Panel - PVP-I Prep Pads Foil Pouch Label)

Dukal

Povidone-Iodine Prep Pad

Sterile

Antiseptic

For Professional and Hospital Use

Not made with natura rubber latex

Sterile unless package is damaged or opened.

Manufactured For: Dukal, LLC

1(800)243-0741 / Ronkonkoma, NY 11779 / dukal.com

Made in China

Dukal is a trademark registered in the

US Patent & Trademark Office by Dukal, LLC

1 Per Pouch - 2 - NDC 6551-0034-1 - REF 882

Principal Display Panel Pvp I Prep Pads Paper Pouch Label (Principal Display Panel - PVP-I Prep Pads Paper Pouch Label)

Dukal

Povidone-Iodine Prep Pad

Sterile

Antiseptic

For Professional and Hospital Use

Not made with natura rubber latex

Sterile unless package is damaged or opened.

Manufactured For: Dukal, LLC

1(800)243-0741 / Ronkonkoma, NY 11779 / dukal.com

Made in China

Dukal is a trademark registered in the

US Patent & Trademark Office by Dukal, LLC Rev1

1 Per Pouch - 2 - NDC 6551-0034-2 - REF 889

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use:": "For preparation prior to surgery. Helps to reduce bacteria that can potentially cause skin infection.", "50565-1": "Keep out of reach of children If swallowed or gets in eyes, get medical help or contact a Poison Control Center right away.", "50566-9": "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.", "50569-3": "Ask a doctor before use if injuries are deep wounds, puncture wounds, serious burns.", "50570-1": "Do not apply to persons allergic to iodine. Do not use in the eyes.", "Purpose:": "Antiseptic", "Warnings:": "For external use only.", "Directions:": "Clean the area. Apply product to the operative site prior to surgery using pad to prep desired area.", "Active Ingredient:": "Povidone Iodine USP 10%", "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 Povidone-Iodine Prep Pad Sterile Antiseptic For Professional and Hospital Use Not made with natura rubber latex Sterile unless package is damaged or opened. Manufactured For: Dukal, LLC 1(800)243-0741 / Ronkonkoma, NY 11779 / dukal.com Made in China Dukal is a trademark registered in the US Patent & Trademark Office by Dukal, LLC 1 Per Pouch - 2 - NDC 6551-0034-1 - REF 882", "Principal Display Panel - PVP-I Prep Pads Paper Pouch Label": "Dukal Povidone-Iodine Prep Pad Sterile Antiseptic For Professional and Hospital Use Not made with natura rubber latex Sterile unless package is damaged or opened. Manufactured For: Dukal, LLC 1(800)243-0741 / Ronkonkoma, NY 11779 / dukal.com Made in China Dukal is a trademark registered in the US Patent & Trademark Office by Dukal, LLC Rev1 1 Per Pouch - 2 - NDC 6551-0034-2 - REF 889"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information