Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID be85ec5b-eb49-4f1a-a87d-5c9705a20f23
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
Citric Acid Monohydrate Glycerin Nonoxynol-10 Water Sodium Hydroxide

Identifiers & Packaging

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

Active Ingredient Povidone-Iodine USP, 10% w/v (equivalent to 1% titratable iodine)

Medication Information

Warnings and Precautions

Warnings

For external use only





Indications and Usage

Use

First aid to help prevent infection in minor cuts, scraps, and burns

Description

Active Ingredient Povidone-Iodine USP, 10% w/v (equivalent to 1% titratable iodine)

Section 50565-1

Keep out of reach of children

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

Section 50566-9

Stop use and consult a doctor

if the condition persists or gets worse

for use longer than 1 week

Section 50569-3

Ask a doctor

in case of deep or puncture wounds, animal bites, serious burns

Section 50570-1

Do not

use in the eyes

apply over large areas of the body

use on individuals who are allergic or sensitive to iodine

Section 51727-6

Inactive Ingredients

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



Section 51945-4

Image of Pouch label

Section 55105-1

Purpose

First Aid Antiseptic

Section 55106-9

Active Ingredient

Povidone-Iodine USP, 10% w/v (equivalent to 1% titratable iodine)

Directions

Clean the affected area

Apply product on the area 1-3 time daily and discard

May be covered with a sterile bandage when dry

Structured Label Content

Indications and Usage (34067-9)

Use

First aid to help prevent infection in minor cuts, scraps, and burns

Warnings and Precautions (34071-1)

Warnings

For external use only





Section 50565-1 (50565-1)

Keep out of reach of children

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

Section 50566-9 (50566-9)

Stop use and consult a doctor

if the condition persists or gets worse

for use longer than 1 week

Section 50569-3 (50569-3)

Ask a doctor

in case of deep or puncture wounds, animal bites, serious burns

Section 50570-1 (50570-1)

Do not

use in the eyes

apply over large areas of the body

use on individuals who are allergic or sensitive to iodine

Section 51727-6 (51727-6)

Inactive Ingredients

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



Section 51945-4 (51945-4)

Image of Pouch label

Section 55105-1 (55105-1)

Purpose

First Aid Antiseptic

Section 55106-9 (55106-9)

Active Ingredient

Povidone-Iodine USP, 10% w/v (equivalent to 1% titratable iodine)

Directions

Clean the affected area

Apply product on the area 1-3 time daily and discard

May be covered with a sterile bandage when dry

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:34.468515 · Updated: 2026-03-14T23:01:28.904310