Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 53cb4c0d-40b5-4cf3-b122-fd6dd654883f
Route
TOPICAL
Published
Effective Date 2010-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (10 mg)
Inactive Ingredients
Water Sodium Hydroxide Nonoxynol-10 Glycerin Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-01-01
Description

Povidone Iodine USP, 10% W/V (equivalent to 1% titratable iodine)

Purpose

Antiseptic

Medication Information

Warnings and Precautions




Warnings For external use only

Indications and Usage

Health-care antiseptic for preparation of the skin prior to surgery First aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes, and burns Use



Purpose

Antiseptic

Description

Povidone Iodine USP, 10% W/V (equivalent to 1% titratable iodine)

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away Keep out of reach of children

Section 50570-1

use in the eyes use on individuals who are allergic or sensitive to iodine apply over larger areas of the body use as a first aid antiseptic longer than 1 week unless by a doctor Do not







Section 51945-4

Image of Pouch Label

Directions

For preparation of the skin prior to surgery

clean the affected area, remove swab by stick apply to the operative site prior to surgery

clean the affected area apply a small amount of this products on the area 1-3 times daily may be covered with a sterile bandage if bandaged, let dry first For use as a first aid antiseptic







Active Ingredient

Povidone Iodine USP, 10% W/V (equivalent to 1% titratable iodine)

Other Information

store at room temperature: 15o - 30oC (59o-86oF)

Inactive Ingredients

citric acid, purified water, sodium hydroxide, Nonoxynol-10, glycerin

Structured Label Content

Indications and Usage (34067-9)

Health-care antiseptic for preparation of the skin prior to surgery First aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes, and burns Use



Warnings and Precautions (34071-1)




Warnings For external use only

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away Keep out of reach of children

Section 50570-1 (50570-1)

use in the eyes use on individuals who are allergic or sensitive to iodine apply over larger areas of the body use as a first aid antiseptic longer than 1 week unless by a doctor Do not







Section 51945-4 (51945-4)

Image of Pouch Label

Purpose

Antiseptic

Directions

For preparation of the skin prior to surgery

clean the affected area, remove swab by stick apply to the operative site prior to surgery

clean the affected area apply a small amount of this products on the area 1-3 times daily may be covered with a sterile bandage if bandaged, let dry first For use as a first aid antiseptic







Active Ingredient

Povidone Iodine USP, 10% W/V (equivalent to 1% titratable iodine)

Other Information (Other information)

store at room temperature: 15o - 30oC (59o-86oF)

Inactive Ingredients (Inactive ingredients)

citric acid, purified water, sodium hydroxide, Nonoxynol-10, glycerin

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:25.013091 · Updated: 2026-03-14T23:07:10.032470