2bebe082-59b6-17c1-e063-6294a90a9a52

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
Purpose

Antiseptic

Description

Povidone-Iodine USP 10%

Medication Information

Warnings

For External Use Only

Purpose

Antiseptic

Directions

apply product to skin as needed

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

Description

Povidone-Iodine USP 10%

Use

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

Do Not Use
  • if allergic to iodine
  • in the eyes
Active Ingredient

Povidone-Iodine USP 10%

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

Warnings

For External Use Only

Purpose

Antiseptic

Directions

apply product to skin as needed

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

Use

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

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

Povidone-Iodine USP 10%

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