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
Description

Povidone-lodine USP 10%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Povidone-lodine USP 10%

Use

for antiseptic skin preparation

Storage

Avoid excessive heat

Store at room temperature

Warnings

For external use only

Avoid pooling beneath patient

Directions

apply locally as needed

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

Povidone-lodine USP 10%

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

Use

for antiseptic skin preparation

Purpose

Antiseptic

Storage

Avoid excessive heat

Store at room temperature

Warnings

For external use only

Avoid pooling beneath patient

Directions

apply locally as needed

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

Povidone-lodine USP 10%

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