65517-0040

65517-0040
SPL v3
SPL
SPL Set ID f6f5dc9a-b578-70c1-e053-6394a90acdb0
Route
TOPICAL
Published
Effective Date 2022-09-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (1.1 g)
Inactive Ingredients
Anhydrous Citric Acid Potassium Iodide Glycerin Nonoxynol-10 Water C12-20 Alkyl Glucoside Sodium Lauryl Sulfate Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-15
Description

Povidone-Iodine USP 10%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Povidone-Iodine USP 10%

Use

Patient preoperative skin preparation. Helps to reduc bacteria that potentially can cause skin infection.

Section 50565-1
  • Keep out of reach of children
  • If swallowed or gets in eyes, get medical help or contact Poison Control Center right away.
Section 50566-9

Stop use and ask doctor if infection occurs, redness, irritation or swelling develops.

Section 50569-3
  • Ask a doctor before use if injuries are deep wounds, puncture wounds, serious burns.
Section 51945-4

Dukal™

Povidone-Iodine

Scrub Sponge

Sticks

Sterile

Antispetic

Drug Facts

Active ingredient Purpose

Povidone Iodine USP 10% Antiseptic

Use Patient preoperative skin preparation. Helps to reduce bacteria

that potentially can cause skin infection.

Warnings

For external use only.

Do no use if allergic to iodine, in the eyes

Sterile unless package is damagedor opened

2 Per Pouch Not Made with Natural Rubber Latex Do not re-use NDC-66517-0040-1 REF 911

Warnings:

For external use only.

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

Apply product to skin as needed.

Active Ingredient

Povidone-Iodine USP 10%

Other Information:

1% titratable iodine, Avoid excessive heat, Store at room temperature, For hospital or professional use only, Not made with natural rubber latex

Inactive Ingredients:

Alkyl Glucoside, Anhydrous Citric Acid, Glycerin, Nonoxynol-10, Potassium Iodide, Purified Water, Sodium Hydroxide, Sodium Lauryl Sulfate

Structured Label Content

Use

Patient preoperative skin preparation. Helps to reduc bacteria that potentially can 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 Poison Control Center right away.
Section 50566-9 (50566-9)

Stop use and ask doctor if infection occurs, redness, irritation or swelling develops.

Section 50569-3 (50569-3)
  • Ask a doctor before use if injuries are deep wounds, puncture wounds, serious burns.
Section 51945-4 (51945-4)

Dukal™

Povidone-Iodine

Scrub Sponge

Sticks

Sterile

Antispetic

Drug Facts

Active ingredient Purpose

Povidone Iodine USP 10% Antiseptic

Use Patient preoperative skin preparation. Helps to reduce bacteria

that potentially can cause skin infection.

Warnings

For external use only.

Do no use if allergic to iodine, in the eyes

Sterile unless package is damagedor opened

2 Per Pouch Not Made with Natural Rubber Latex Do not re-use NDC-66517-0040-1 REF 911

Purpose

Antiseptic

Warnings:

For external use only.

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

Apply product to skin as needed.

Active Ingredient

Povidone-Iodine USP 10%

Other Information:

1% titratable iodine, Avoid excessive heat, Store at room temperature, For hospital or professional use only, Not made with natural rubber latex

Inactive Ingredients:

Alkyl Glucoside, Anhydrous Citric Acid, Glycerin, Nonoxynol-10, Potassium Iodide, Purified Water, Sodium Hydroxide, Sodium Lauryl Sulfate

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:18.841790 · Updated: 2026-03-14T23:10:35.893664