ae606094-7085-2247-e053-2a95a90afc9d

SPL v3

SPL

SPL Set ID ae606094-7085-2247-e053-2a95a90afc9d

Route

topical

Published

Effective Date 2020-09-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

iodine (10 g)

Inactive Ingredients

glycerin potassium iodide hydroxyethyl cellulose (100 mpa.s at 2%) water citric acid monohydrate sodium hydroxide nonoxynol-10 c12-20 alkyl glucoside

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2020-09-04

Purpose

Antiseptic

Description

Povidone Iodine USP, 10% w/w

Medication Information

Warnings

For external use only.

Discontinue use if irritation and redness develop.

Purpose

Antiseptic

Directions

Open packet and use as a washcloth.

Description

Povidone Iodine USP, 10% w/w

Use

Antiseptic for preparation of the skin.

Drug Facts

Active Ingredient

Povidone Iodine USP, 10% w/w

Inactive Ingredient

Ctric Acid, Alkyl Glucoside, Hydroxyethyl Cellulose, Nonoxynol-10, Glycerin, Sodium Hydroxide, Potassium Iodide, Purified Water.

Caution: Keep Out of Reach of Children

If swallowed, get medical help or contact Poison Control Center right away.

Structured Label Content

Warnings (WARNINGS)

For external use only.

Discontinue use if irritation and redness develop.

Purpose

Antiseptic

Directions

Open packet and use as a washcloth.

Use

Antiseptic for preparation of the skin.

Drug Facts (DRUG FACTS)

Active Ingredient (Active ingredient)

Povidone Iodine USP, 10% w/w

Inactive Ingredient (INACTIVE INGREDIENT)

Ctric Acid, Alkyl Glucoside, Hydroxyethyl Cellulose, Nonoxynol-10, Glycerin, Sodium Hydroxide, Potassium Iodide, Purified Water.

Caution: Keep Out of Reach of Children (CAUTION: Keep out of reach of children)

If swallowed, get medical help or contact Poison Control Center right away.

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM IODIDE", "unii": "1C4QK22F9J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)", "unii": "R33S7TK2EP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "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": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "NONOXYNOL-10", "unii": "K7O76887AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "C12-20 ALKYL GLUCOSIDE", "unii": "K67N5Z1RUA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "Antiseptic for preparation of the skin.", "Purpose": "Antiseptic", "WARNINGS": "For external use only. Discontinue use if irritation and redness develop.", "Directions": "Open packet and use as a washcloth.", "Active ingredient": "Povidone Iodine USP, 10% w/w", "INACTIVE INGREDIENT": "Ctric Acid, Alkyl Glucoside, Hydroxyethyl Cellulose, Nonoxynol-10, Glycerin, Sodium Hydroxide, Potassium Iodide, Purified Water.", "CAUTION: Keep out of reach of children": "If swallowed, get medical help or contact Poison Control Center right away."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:35.429652 · Updated: 2026-03-14T23:02:13.859151