SPL v1
SPL
SPL Set ID 6b89fcf5-5a52-7e20-e053-2a91aa0a08fc
Route
TOPICAL
Published
Effective Date 2018-05-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (100 mg)
Inactive Ingredients
Water Hydroxyethyl Cellulose (100 Mpa.s At 2%) Nonoxynol-10

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-05-03
Description

Active ingredient Povidone Iodine 10%

Medication Information

Warnings and Precautions

Warnings

For external use only. Do not use in the eyes.

Indications and Usage

Uses For cleansing hands and arms prior to surgery

Dosage and Administration

Direction

  • Wet hands and forearms with water
  • Clean under nails with nail cleaner
  • Scrub for 3 minutes with the impregnated brush
  • Pay close attention to the nails, cuticles, and interdigital spaces
  • Rinse thoroughly with running water
  • Repeat
Description

Active ingredient Povidone Iodine 10%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if Skin shows symptons of irritation, sensitivity, redness, pain or swelling

Section 51727-6

Inactive ingredients

Hydroxyethylcellulose, Nonoxynol ethoxylate, Purified Water

Section 51945-4

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active ingredient

Povidone Iodine 10%

Section 60561-8

Other information

  • Store at room temperature
  • Avoid excessive heat above 40 °C (104 °F)
  • Protect from freezing
  • Latex free

Structured Label Content

Indications and Usage (34067-9)

Uses For cleansing hands and arms prior to surgery

Dosage and Administration (34068-7)

Direction

  • Wet hands and forearms with water
  • Clean under nails with nail cleaner
  • Scrub for 3 minutes with the impregnated brush
  • Pay close attention to the nails, cuticles, and interdigital spaces
  • Rinse thoroughly with running water
  • Repeat
Warnings and Precautions (34071-1)

Warnings

For external use only. Do not use in the eyes.

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 50566-9 (50566-9)

Stop use and ask a doctor if Skin shows symptons of irritation, sensitivity, redness, pain or swelling

Section 51727-6 (51727-6)

Inactive ingredients

Hydroxyethylcellulose, Nonoxynol ethoxylate, Purified Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active ingredient

Povidone Iodine 10%

Section 60561-8 (60561-8)

Other information

  • Store at room temperature
  • Avoid excessive heat above 40 °C (104 °F)
  • Protect from freezing
  • Latex free

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:33.745657 · Updated: 2026-03-14T22:55:06.338046