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
Description

Povidone Iodine USP, 10% w/w

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Povidone Iodine USP, 10% w/w

Use

Antiseptic for preparation of the skin.

Warnings

For external use only.

Discontinue use if irritation and redness develop.

Drug Facts

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.

Structured Label Content

Use

Antiseptic for preparation of the skin.

Purpose

Antiseptic

Warnings (WARNINGS)

For external use only.

Discontinue use if irritation and redness develop.

Drug Facts (DRUG FACTS)

Directions

Open packet and use as a washcloth.

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

Raw Label Data

All Sections (JSON)

Additional Information

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