65517-0033

65517-0033
SPL v9
SPL
SPL Set ID 5af20b49-11b1-4b15-bb7f-eccda2c46997
Route
TOPICAL
Published
Effective Date 2024-02-28
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 Potassium Iodide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-01-31
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.
Purpose:

Antiseptic

Warnings:

For external use only.

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

Clean the area. Apply product to the operative site prior to surgery using sponge sticks 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 Swabstick Sterile 883 Pouch Label

Dukal

Povidone-Iodine

Swabstick

Sterile

Antiseptic

Drug Facts

Active Ingredient Purpose

Povidone Iodine USP 10% Antiseptic

Use Patient preoperative skin reparation: Helps to reduce bacteria that potentially can cause skin infection.

Sterile unless package is damaged or opened.

3 Per Pouch - Do not re-use - NDC 6551-0033-3 - REF 883

Principal Display Panel Pvp I Prep Swabstick Sterile 884 Pouch Label

Dukal

Povidone-Iodine

Swabstick

Sterile

Antiseptic

Drug Facts

Active Ingredient Purpose

Povidone Iodine USP 10% Antiseptic

Use Patient preoperative skin reparation: Helps to reduce bacteria that potentially can cause skin infection.

Sterile unless package is damaged or opened.

1 Per Pouch - 2 - NDC 6551-0033-1 - REF 884

Principal Display Panel Pvp I Prep Swabstick Sterile 883c Pouch Label

Dukal

Povidone-Iodine

Swabstick

Sterile

Antiseptic

Drug Facts

Active Ingredient Purpose

Povidone Iodine USP 10% Antiseptic

Use Patient preoperative skin reparation: Helps to reduce bacteria that potentially can cause skin infection.

Sterile unless package is damaged or opened.

3 Per Pouch - Do not re-use - NDC 6551-0033-3 - REF 883C

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.
Purpose:

Antiseptic

Warnings:

For external use only.

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

Clean the area. Apply product to the operative site prior to surgery using sponge sticks 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 Swabstick Sterile 883 Pouch Label (Principal Display Panel - PVP-I Prep Swabstick Sterile 883 Pouch Label)

Dukal

Povidone-Iodine

Swabstick

Sterile

Antiseptic

Drug Facts

Active Ingredient Purpose

Povidone Iodine USP 10% Antiseptic

Use Patient preoperative skin reparation: Helps to reduce bacteria that potentially can cause skin infection.

Sterile unless package is damaged or opened.

3 Per Pouch - Do not re-use - NDC 6551-0033-3 - REF 883

Principal Display Panel Pvp I Prep Swabstick Sterile 884 Pouch Label (Principal Display Panel - PVP-I Prep Swabstick Sterile 884 Pouch Label)

Dukal

Povidone-Iodine

Swabstick

Sterile

Antiseptic

Drug Facts

Active Ingredient Purpose

Povidone Iodine USP 10% Antiseptic

Use Patient preoperative skin reparation: Helps to reduce bacteria that potentially can cause skin infection.

Sterile unless package is damaged or opened.

1 Per Pouch - 2 - NDC 6551-0033-1 - REF 884

Principal Display Panel Pvp I Prep Swabstick Sterile 883c Pouch Label (Principal Display Panel - PVP-I Prep Swabstick Sterile 883C Pouch Label)

Dukal

Povidone-Iodine

Swabstick

Sterile

Antiseptic

Drug Facts

Active Ingredient Purpose

Povidone Iodine USP 10% Antiseptic

Use Patient preoperative skin reparation: Helps to reduce bacteria that potentially can cause skin infection.

Sterile unless package is damaged or opened.

3 Per Pouch - Do not re-use - NDC 6551-0033-3 - REF 883C

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:17.932157 · Updated: 2026-03-14T23:10:33.744870