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

Active Ingredient

Active Ingredients

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

Indications and Usage

Uses

Prepping intact skin and mucous membranes prior to surgery

Other Information

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

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

Package Label

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only

Avoid use on persons allergic to iodine

Active Ingredient (55106-9)

Active Ingredients

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

Indications and Usage (34067-9)

Uses

Prepping intact skin and mucous membranes prior to surgery

Other Information (Other information)

store at room temperature avoid excessive heat (above 104oF/40oC) 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

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

Section 55105-1 (55105-1)

Purpose

Antiseptic

Package Label

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