65517-0039-1

65517-0039-1
SPL v4
SPL
SPL Set ID f4596b0c-0e04-d71a-e053-2995a90a3b20
Route
TOPICAL
Published
Effective Date 2023-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

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 2023-02-15

Description

Povidone Iodine USP 10%

Purpose

Antiseptic


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 Paper/foil Pouch Label

Dukal

Povidone-Iodine

Prep Pad

​Non-Sterile

Antiseptic

For Professional and Hospital Use

Not Made with Natural Rubber Latex

Manufactured For: Dukal LLC

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

Made in China

Dukal is a trademark registered in the

US Patent & Trademark Office by Dukal, LLC

1 Per Pouch / 2 / NDC 65517-0039-1 / REF 914


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

Dukal

Povidone-Iodine

Prep Pad

​Non-Sterile

Antiseptic

For Professional and Hospital Use

Not Made with Natural Rubber Latex

Manufactured For: Dukal LLC

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

Made in China

Dukal is a trademark registered in the

US Patent & Trademark Office by Dukal, LLC

1 Per Pouch / 2 / NDC 65517-0039-1 / REF 914


Advanced Ingredient Data


Raw Label Data

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