81526-001

81526-001
SPL v5
SPL
SPL Set ID 690b87d0-d889-43c6-b99e-cd9f26fd682a
Route
TOPICAL
Published
Effective Date 2021-02-04
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 Nonoxynol-9 Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-04
Description

Povidone-Iodine USP (10%)

Purpose

Antiseptic

Medication Information

Warnings and Precautions

Warnings:

Do not use if allergic to iodine in eyes

For external use only

Avoid "pooling" beneath patients. 

Avoid excessive heat. Store at room temperature.

Purpose

Antiseptic

Dosage and Administration

Apply locally as need

Description

Povidone-Iodine USP (10%)

Use:

Antiseptic skin preparation

Section 50565-1

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

Section 50569-3

Ask a doctor before use if injuries are deep or puncture wounds, or serious burns

Stop use and ask a doctor if

  • redness, irritation, swelling, or pain persists or increases
  • infection occurs
Section 51945-4

Section 60561-8

Other information

  • 1% titratable iodine
  • not made with natural rubber latex
  • for hospital or professional use only
Active Ingredient:

Povidone-Iodine USP (10%)

Inactive Ingredient

Citric acid, Disodium phosphate, Nonoxynol-9, Sodium hydroxide, Water

Structured Label Content

Use:

Antiseptic skin preparation

Dosage and Administration (34068-7)

Apply locally as need

Warnings and Precautions (34071-1)

Warnings:

Do not use if allergic to iodine in eyes

For external use only

Avoid "pooling" beneath patients. 

Avoid excessive heat. Store at room temperature.

Section 50565-1 (50565-1)

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

Section 50569-3 (50569-3)

Ask a doctor before use if injuries are deep or puncture wounds, or serious burns

Stop use and ask a doctor if

  • redness, irritation, swelling, or pain persists or increases
  • infection occurs
Section 51945-4 (51945-4)

Section 60561-8 (60561-8)

Other information

  • 1% titratable iodine
  • not made with natural rubber latex
  • for hospital or professional use only
Purpose

Antiseptic

Active Ingredient:

Povidone-Iodine USP (10%)

Inactive Ingredient

Citric acid, Disodium phosphate, Nonoxynol-9, Sodium hydroxide, Water

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:22.958523 · Updated: 2026-03-14T23:07:05.651363