SPL v2
SPL
SPL Set ID 2bebe082-59b6-17c1-e063-6294a90a9a52
Route
TOPICAL
Published
Effective Date 2025-01-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (1 g)
Inactive Ingredients
Water Sodium Hydroxide Hydroxyethyl Cellulose (2000 Cps At 1%) Nonoxynol-10 Glycerin Anhydrous Citric Acid C12-20 Alkyl Glucoside Potassium Iodide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-21
Description

Povidone-Iodine USP 10%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Povidone-Iodine USP 10%

Use

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

Warnings

For External Use Only

Directions

apply product to skin as needed

Do Not Use
  • if allergic to iodine
  • in the eyes
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, Citric Acid, Glycerin, Hydroxyethyl Cellulose, Nonoxynol-10, Potassium Iodide, Sodium hydroxide, Water

Principle Display Panel

Duka

Povidone-Iodine

Gel

Non-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.

1 fl oz (29.5ml) Do not re-use NDC-66517-0070-1 REF 916

Stop Use and Ask Doctor
  • infection occurs
  • redness, irritation or swelling develops
Keep Out of Reach of Children

If swallowed, get medical help or contact Poison Control Center right away

Ask A Doctor Before Use If Injuries Are
  • deep or puncture wounds
  • serious burn

Structured Label Content

Use

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

Purpose

Antiseptic

Warnings

For External Use Only

Directions

apply product to skin as needed

Do Not Use (Do not use)
  • if allergic to iodine
  • in the eyes
Active Ingredient

Povidone-Iodine USP 10%

Other Information (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, Citric Acid, Glycerin, Hydroxyethyl Cellulose, Nonoxynol-10, Potassium Iodide, Sodium hydroxide, Water

Principle Display Panel

Duka

Povidone-Iodine

Gel

Non-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.

1 fl oz (29.5ml) Do not re-use NDC-66517-0070-1 REF 916

Stop Use and Ask Doctor (Stop use and ask doctor)
  • infection occurs
  • redness, irritation or swelling develops
Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact Poison Control Center right away

Ask A Doctor Before Use If Injuries Are (Ask a doctor before use if injuries are)
  • deep or puncture wounds
  • serious burn

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:17.038004 · Updated: 2026-03-14T23:10:33.744870