Povidone-iodine Solution, Sterile

Povidone-iodine Solution, Sterile
SPL v7
SPL
SPL Set ID b1910bf8-9e96-4df1-8cca-6926102ad235
Route
TOPICAL
Published
Effective Date 2024-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (10 g)
Inactive Ingredients
Citric Acid Monohydrate Glycerin Hydroxyethyl Cellulose, Unspecified Nonoxynol-10 Potassium Iodide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-06-29
Description

Povidone-lodine 10%w/w

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Povidone-lodine 10%w/w

Use

for antiseptic skin preparation

Driections

Apply product to skin as needed.

Drug Facts

Do Not Use
  • if allergic to lodine
  • do not use in the eyes
Active Ingredient

Povidone-lodine 10%w/w

Other Information
  • 1% titratable iodine
  • for hospital or professional use only
Package Labeling:

Inactive Ingredients:

Alkyl glucoside,citric acid,glycerin, hydroxyethyl cellulose,nonoxynol-10, potassium iodide, purified water, hydroxode

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

In case of accidental ingestion, seek professional assistance or consult a Poison Control Center immediately.

Avoid pooling beneath patient.

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

Structured Label Content

Use

for antiseptic skin preparation

Purpose

Antiseptic

Driections

Apply product to skin as needed.

Drug Facts

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

Povidone-lodine 10%w/w

Other Information (Other information)
  • 1% titratable iodine
  • for hospital or professional use only
Package Labeling:

Inactive Ingredients: (Inactive ingredients:)

Alkyl glucoside,citric acid,glycerin, hydroxyethyl cellulose,nonoxynol-10, potassium iodide, purified water, hydroxode

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • redness, irritation, swelling or pain persists or increases
  • infection occurs
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.

Avoid pooling beneath patient.

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:30.038705 · Updated: 2026-03-14T23:05:17.700396