Drug Facts

Drug Facts

SPL v6

SPL

SPL Set ID 9377d7e8-e7b5-40e1-ba91-decb476c0752

Route

TOPICAL

Published

Effective Date 2017-12-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Iodine (100 mg)

Inactive Ingredients

Nonoxynol-10 Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2010-01-01

Description

Active Ingredients Povidone Iodine 10%

Medication Information

Warnings and Precautions

Warnings

For external use only

Do not use in the eyes

Indications and Usage

Use

For cleansing hands and arms prior to surgery

Dosage and Administration

Directions

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 Ingredients Povidone Iodine 10%

Section 44425-7

Other Information

Store at room temperature

Avoid excessive heat above 40 ^o C (104 ^oF)

Protect from freezing

Latex free

Section 50565-1

Keep out of reach of children

If swallowed, get medical help or contact Poison Control Center right away

Section 50566-9

Stop Use and ask a doctor if

Skin shows symptoms of irritation, sensitivity, redness, pain or swelling

Section 51727-6

Inactive Ingredients

Hydroxyethylcellulose, Nonoxynol - 10, Purified Water

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active Ingredients

Povidone Iodine 10%

Package Label

Structured Label Content

Indications and Usage (34067-9)

Use

For cleansing hands and arms prior to surgery

Dosage and Administration (34068-7)

Directions

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 44425-7 (44425-7)

Other Information

Store at room temperature

Avoid excessive heat above 40 ^o C (104 ^oF)

Protect from freezing

Latex free

Section 50565-1 (50565-1)

Keep out of reach of children

If swallowed, get medical help or contact Poison Control Center right away

Section 50566-9 (50566-9)

Stop Use and ask a doctor if

Skin shows symptoms of irritation, sensitivity, redness, pain or swelling

Section 51727-6 (51727-6)

Inactive Ingredients

Hydroxyethylcellulose, Nonoxynol - 10, Purified Water

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active Ingredients

Povidone Iodine 10%

Package Label

Advanced Ingredient Data

[{"name": "NONOXYNOL-10", "unii": "K7O76887AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "IODINE", "unii": "9679TC07X4", "classCode": "ACTIM", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Use For cleansing hands and arms prior to surgery", "34068-7": "Directions 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", "34071-1": "Warnings For external use only Do not use in the eyes", "44425-7": "Other Information Store at room temperature Avoid excessive heat above 40 o C (104 o F) Protect from freezing Latex free", "50565-1": "Keep out of reach of children If swallowed, get medical help or contact Poison Control Center right away", "50566-9": "Stop Use and ask a doctor if Skin shows symptoms of irritation, sensitivity, redness, pain or swelling", "51727-6": "Inactive Ingredients Hydroxyethylcellulose, Nonoxynol - 10, Purified Water", "55105-1": "Purpose Antiseptic", "55106-9": "Active Ingredients Povidone Iodine 10%"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:59:29.073904 · Updated: 2026-03-14T22:59:28.137987