povidone-iodine solution, sterile

povidone-iodine solution, sterile
SPL v2
SPL
SPL Set ID 0e8baf24-0c67-5511-e063-6394a90acaa1
Route
topical
Published
Effective Date 2023-09-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
iodine (10 g)
Inactive Ingredients
nonoxynol-10 glycerin water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-09-27
Purpose

Antiseptic

Description

Povidone-lodine USP 10%

Medication Information

Warnings

For external use only

Avoid pooling beneath patient

Purpose

Antiseptic

Directions

apply locally as needed

Other Information
  • 1% titratable iodine
  • for hospital or professional use only
Description

Povidone-lodine USP 10%

Use

for antiseptic skin preparation

Storage

Avoid excessive heat

Store at room temperature

Do Not Use
  • if allergic to lodine
  • in the eye
Active Ingredient

Povidone-lodine USP 10%

Package Labeling:

NDC 83645-552-11

ADI Medical

Inactive Ingredients:

Nonyl Nonoxynol-10, Glycerin, Purifed Water.

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.

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

Structured Label Content

Warnings

For external use only

Avoid pooling beneath patient

Purpose

Antiseptic

Directions

apply locally as needed

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

for antiseptic skin preparation

Storage

Avoid excessive heat

Store at room temperature

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

Povidone-lodine USP 10%

Package Labeling:

NDC 83645-552-11

ADI Medical

Inactive Ingredients: (Inactive ingredients:)

Nonyl Nonoxynol-10, Glycerin, Purifed Water.

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.

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: 2026-02-15T12:05:33.389984 · Updated: 2026-03-14T23:07:34.278056