0126 Povidone-iodine Ointment

0126 Povidone-iodine Ointment
SPL v5
SPL
SPL Set ID c6190453-4385-4be5-b4b9-4637b4e84845
Route
TOPICAL
Published
Effective Date 2017-05-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (10 mg)
Inactive Ingredients
Glycerin Propylene Glycol Polyethylene Glycol 1450

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Completed Since 2017-05-31 Until 2025-12-31
Description

Povidone-iodine USP 10%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Povidone-iodine USP 10%

Use

antiseptic skin preparation

Section 44425-7
  • Avoid excessive heat. Store at room temperature.
Warnings
  • For external use only
Directions

Apply locally as needed.

Do Not Use
  • if allergic to iodine or in the eyes
Package Label

Active Ingredient

Povidone-iodine USP 10%

Other Information
  • 1% titratable iodine
  • Not made with natural rubber latex
  • for hospital or professional use only
Inactive Ingredients

glycerin, polyethylene glycol, propylene glycol

Stop Use and Ask A Doctor
  • if infection occurs or if redness, irritation, swelling or pain persists or increases.
Keep Out of Reach of Children.

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

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

Structured Label Content

Use

antiseptic skin preparation

Section 44425-7 (44425-7)
  • Avoid excessive heat. Store at room temperature.
Purpose

Antiseptic

Warnings
  • For external use only
Directions

Apply locally as needed.

Do Not Use (Do not use)
  • if allergic to iodine or in the eyes
Package Label

Active Ingredient

Povidone-iodine USP 10%

Other Information
  • 1% titratable iodine
  • Not made with natural rubber latex
  • for hospital or professional use only
Inactive Ingredients (Inactive ingredients)

glycerin, polyethylene glycol, propylene glycol

Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • if infection occurs or if redness, irritation, swelling or pain persists or increases.
Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:34.588857 · Updated: 2026-03-14T23:01:01.701433