Drug Facts

Drug Facts

SPL v6

SPL

SPL Set ID 14f2a1dd-92c2-49e8-9fa0-a9d88e8c530d

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

Nonoxynol-10 Water

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

For preparation of skin and mucous membranes prior to surgery

Dosage and Administration

Directions

open pouch at tear notch

use sponge sticks to prep desired area

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

hydroxyethylcellulose, nonoxynol - 10, purified water

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active Ingredients

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

Package Labeling

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

For preparation of skin and mucous membranes prior to surgery

Dosage and Administration (34068-7)

Directions

open pouch at tear notch

use sponge sticks to prep desired area

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

hydroxyethylcellulose, nonoxynol - 10, purified water

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active Ingredients

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

Package Labeling

Other Information (Other information)

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

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": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses For preparation of skin and mucous membranes prior to surgery", "34068-7": "Directions open pouch at tear notch use sponge sticks to prep desired area", "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 hydroxyethylcellulose, nonoxynol - 10, purified water", "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: 2026-02-15T12:01:34.421393 · Updated: 2026-03-14T23:01:27.375563