65517-0035

65517-0035
SPL v13
SPL
SPL Set ID 45aefabf-5283-411a-b509-749977635938
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 Citric Acid Monohydrate Sodium Hydroxide Water C12-20 Alkyl Glucoside 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 50570-1

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

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

Antiseptic

Warnings:

For external use only.

Directions:

Clean the area. Apply product to the operative site prior to surgery.

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 1 Oz Pouch Label

Dukal

Povidone-Iodine

1 Fluid Ounce

Solution

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 fl oz (29.5 ml) - 2 - NDC 6551-0035-2 - REF 886

Principal Display Panel 3/4 Oz Pouch Label

Dukal

Povidone-Iodine

3/4 Fluid Ounce

Solution

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.

0.75 fl oz (22.5 ml) - 2 - NDC 6551-0035-1 - REF 885

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 50570-1 (50570-1)

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

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

Antiseptic

Warnings:

For external use only.

Directions:

Clean the area. Apply product to the operative site prior to surgery.

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 1 Oz Pouch Label (Principal Display Panel - 1 oz Pouch Label)

Dukal

Povidone-Iodine

1 Fluid Ounce

Solution

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 fl oz (29.5 ml) - 2 - NDC 6551-0035-2 - REF 886

Principal Display Panel 3/4 Oz Pouch Label (Principal Display Panel - 3/4 oz Pouch Label)

Dukal

Povidone-Iodine

3/4 Fluid Ounce

Solution

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.

0.75 fl oz (22.5 ml) - 2 - NDC 6551-0035-1 - REF 885

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:17.913682 · Updated: 2026-03-14T23:10:33.744870