6b89fcf5-5a52-7e20-e053-2a91aa0a08fc

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.

Active Ingredient

Active ingredient

Povidone Iodine 10%

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 60561-8

Other information

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

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

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

Active Ingredient (55106-9)

Active ingredient

Povidone Iodine 10%

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
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 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