Op-first Aid Series Povidone Iodine Prep Pad

Op-first Aid Series Povidone Iodine Prep Pad
SPL v2
SPL
SPL Set ID 32dc994b-6636-72d8-e063-6294a90a98f6
Route
TOPICAL
Published
Effective Date 2025-04-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (1 g)
Inactive Ingredients
Water Citric Acid Monohydrate Sodium Phosphate, Dibasic

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-18
Description

Active Ingredien t: Povidone-Iodine 10% USP (equivalent to iodine 1%)

Medication Information

Warnings and Precautions

Warnings:

  • For external use only

Indications and Usage

Use

  • Antiseptic for preparation of the skin.
  • First aid antiseptic to help prevent skin infection.
Dosage and Administration

Directions

Clean intended area thoroughly with pad, discard after single use.

Description

Active Ingredien t: Povidone-Iodine 10% USP (equivalent to iodine 1%)

Section 50565-1

Keep out of reach of children

If swallowed get medical help or contact a poison control center right away.

Section 50569-3

Stop use

In case of deep or puncture wounds or serious burns and if pain, irritation, redness, swelling, or infection occurs, discontinue use and contact a physician.

Section 51727-6

Inactive Ingredients

Citric acid, disodiumphosphate, purified water.

Section 51945-4

Section 55105-1

Purpose: Antiseptic

Section 55106-9

Active Ingredient: Povidone-Iodine 10% USP (equivalent to iodine 1%)

Section 60561-8

Other information​

Store at room temperature 15ºC-30ºC (59ºF-86ºF)

Structured Label Content

Indications and Usage (34067-9)

Use

  • Antiseptic for preparation of the skin.
  • First aid antiseptic to help prevent skin infection.
Dosage and Administration (34068-7)

Directions

Clean intended area thoroughly with pad, discard after single use.

Warnings and Precautions (34071-1)

Warnings:

  • For external use only

Section 50565-1 (50565-1)

Keep out of reach of children

If swallowed get medical help or contact a poison control center right away.

Section 50569-3 (50569-3)

Stop use

In case of deep or puncture wounds or serious burns and if pain, irritation, redness, swelling, or infection occurs, discontinue use and contact a physician.

Section 51727-6 (51727-6)

Inactive Ingredients

Citric acid, disodiumphosphate, purified water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Antiseptic

Section 55106-9 (55106-9)

Active Ingredient: Povidone-Iodine 10% USP (equivalent to iodine 1%)

Section 60561-8 (60561-8)

Other information​

Store at room temperature 15ºC-30ºC (59ºF-86ºF)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:12.199486 · Updated: 2026-03-14T23:08:50.768383