SPL v1
SPL
SPL Set ID 33f08f03-93fb-214d-e063-6394a90a73bd
Route
TOPICAL
Published
Effective Date 2025-04-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (10 mg)
Inactive Ingredients
Citric Acid Monohydrate Sodium Phosphate, Dibasic, Anhydrous Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2007-01-01

Description

Povidone-Iodine, 10% w/w


Medication Information

Warnings and Precautions

For external use only.

Do not use

in the eyes

longer than 1 week unless directed by a physician

on individuals who are allergic or sensitive to iodine

or apply over large areas of the body

Stop use and ask a doctor if

irritation and redness develop

condition persists for more than 72 hours

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

Keep out of reach of children.

If swallowed, get medical assistance or immediately contact a Poison Control Center.

Indications and Usage

clean the affected area

apply a small amount of this product on the area 1 to 3 times daily.

may be covered with a sterile bandage

if bandaged, let dry first

Dosage and Administration

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



clean the affected area

apply a small amount of this product on the area 1 to 3 times daily.

may be covered with a sterile bandage

if bandaged, let dry first

Description

Povidone-Iodine, 10% w/w

Uses

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

Section 50565-1

Keep out of reach of children.

If swallowed, get medical assistance or immediately contact a Poison Control Center.

Section 50566-9

Stop use and ask a doctor if

irritation and redness develop

condition persists for more than 72 hours

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

Section 50569-3

Stop use and ask a doctor if

irritation and redness develop

condition persists for more than 72 hours

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

Section 51727-6

citric acid, disodium phosphate, water

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

Povidone-Iodine, 10% w/w

Section 60561-8

do not flush

protect from freezing, avoid excessive heat

Directions

clean the affected area

apply a small amount of this product on the area 1 to 3 times daily.

may be covered with a sterile bandage

if bandaged, let dry first


Structured Label Content

Uses (USES)

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

Indications and Usage (34067-9)

clean the affected area

apply a small amount of this product on the area 1 to 3 times daily.

may be covered with a sterile bandage

if bandaged, let dry first

Dosage and Administration (34068-7)

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



clean the affected area

apply a small amount of this product on the area 1 to 3 times daily.

may be covered with a sterile bandage

if bandaged, let dry first

Warnings and Precautions (34071-1)

For external use only.

Do not use

in the eyes

longer than 1 week unless directed by a physician

on individuals who are allergic or sensitive to iodine

or apply over large areas of the body

Stop use and ask a doctor if

irritation and redness develop

condition persists for more than 72 hours

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

Keep out of reach of children.

If swallowed, get medical assistance or immediately contact a Poison Control Center.

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical assistance or immediately contact a Poison Control Center.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

irritation and redness develop

condition persists for more than 72 hours

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

Section 50569-3 (50569-3)

Stop use and ask a doctor if

irritation and redness develop

condition persists for more than 72 hours

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

Section 51727-6 (51727-6)

citric acid, disodium phosphate, water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Povidone-Iodine, 10% w/w

Section 60561-8 (60561-8)

do not flush

protect from freezing, avoid excessive heat

Directions (DIRECTIONS)

clean the affected area

apply a small amount of this product on the area 1 to 3 times daily.

may be covered with a sterile bandage

if bandaged, let dry first


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)