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

Active Ingredient

Active Ingredients

Povidone Iodine 10%

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

Package Label

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only

Do not use in the eyes

Active Ingredient (55106-9)

Active Ingredients

Povidone Iodine 10%

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

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

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

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