drug facts

drug facts

SPL v1

SPL

SPL Set ID be88cbf9-4e86-4f59-91cf-1fe261ed8e43

Route

topical

Published

Effective Date 2010-03-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

iodine (10 1)

Inactive Ingredients

nonoxynol-10 glycerin silicon dioxide dimethicone sodium phosphate, dibasic anhydrous water

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 1998-09-01

Description

Povidone-iodine

Medication Information

Warnings and Precautions

Avoid "pooling" beneath patient. Prolonged exposure to wet solution may cause skin irritation.

Active Ingredient

Povidone-iodine

Description

Povidone-iodine

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

Stop use and ask a doctor if

infection occurs
redness, irritation, swelling or pain persists or increases

Ask a doctor before use if injuries are

deep puncture wounds
serious burns

Section 50570-1

Do not use if allergic to iodine.

Do not use in eyes.

Section 51945-4

Bottle Label

Section 55105-1

Antiseptic

Structured Label Content

Warnings and Precautions (34071-1)

Avoid "pooling" beneath patient. Prolonged exposure to wet solution may cause skin irritation.

Active Ingredient (55106-9)

Povidone-iodine

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)

Stop use and ask a doctor if

infection occurs
redness, irritation, swelling or pain persists or increases

Ask a doctor before use if injuries are

deep puncture wounds
serious burns

Section 50570-1 (50570-1)

Do not use if allergic to iodine.

Do not use in eyes.

Section 51945-4 (51945-4)

Bottle Label

Section 55105-1 (55105-1)

Antiseptic

Advanced Ingredient Data

[{"name": "Iodine", "unii": "9679TC07X4", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "100", "strengthNumeratorUnit": "1", "strengthDenominatorUnit": "g"}, {"name": "Nonoxynol-10", "unii": "K7O76887AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Glycerin", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Silicon Dioxide", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Dimethicone", "unii": "92RU3N3Y1O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Phosphate, Dibasic Anhydrous", "unii": "22ADO53M6F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34071-1": "Avoid "pooling" beneath patient. Prolonged exposure to wet solution may cause skin irritation.", "50565-1": "Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.", "50569-3": "Stop use and ask a doctor if infection occurs redness, irritation, swelling or pain persists or increases Ask a doctor before use if injuries are deep puncture wounds serious burns", "50570-1": "Do not use if allergic to iodine. Do not use in eyes.", "51945-4": "Bottle Label", "55105-1": "Antiseptic", "55106-9": "Povidone-iodine"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:02.242099 · Updated: 2026-03-14T22:52:21.082332