Drug Facts

Drug Facts

SPL v6

SPL

SPL Set ID 0bd3de76-b726-41f1-87bc-14ab8a1eca8e

Route

TOPICAL

Published

Effective Date 2017-12-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Iodine (10 mg)

Inactive Ingredients

Citric Acid Monohydrate Glycerin Nonoxynol-10 Water Sodium Hydroxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2010-01-01

Description

Active Ingredients Povidone Iodine, USP 10% (1.0% available Iodine)

Medication Information

Warnings and Precautions

Warnings

For external use only

Avoid use on persons allergic to iodine

Indications and Usage

Uses

Prepping intact skin and mucous membranes prior to surgery

Description

Active Ingredients Povidone Iodine, USP 10% (1.0% available Iodine)

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

Citric Acid, Glycerin, Nonoxynol - 10, Purified Water, Sodium hydroxide, hydroxyethylcellulose

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active Ingredients

Povidone Iodine, USP 10% (1.0% available Iodine)

Package Label

Other Information

store at room temperature avoid excessive heat (above 104oF/40oC) protect from freezing latex free

Structured Label Content

Indications and Usage (34067-9)

Uses

Prepping intact skin and mucous membranes prior to surgery

Warnings and Precautions (34071-1)

Warnings

For external use only

Avoid use on persons allergic to iodine

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

Citric Acid, Glycerin, Nonoxynol - 10, Purified Water, Sodium hydroxide, hydroxyethylcellulose

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active Ingredients

Povidone Iodine, USP 10% (1.0% available Iodine)

Package Label

Other Information (Other information)

store at room temperature avoid excessive heat (above 104oF/40oC) protect from freezing latex free

Advanced Ingredient Data

[{"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NONOXYNOL-10", "unii": "K7O76887AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "IODINE", "unii": "9679TC07X4", "classCode": "ACTIM", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses Prepping intact skin and mucous membranes prior to surgery", "34071-1": "Warnings For external use only Avoid use on persons allergic to iodine", "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 Citric Acid, Glycerin, Nonoxynol - 10, Purified Water, Sodium hydroxide, hydroxyethylcellulose", "55105-1": "Purpose Antiseptic", "55106-9": "Active Ingredients Povidone Iodine, USP 10% (1.0% available Iodine)", "Other information": "store at room temperature avoid excessive heat (above 104oF/40oC) protect from freezing latex free"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:34.419636 · Updated: 2026-03-14T23:01:27.375563