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





Active Ingredient

Active Ingredient

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

Indications and Usage

Use

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

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

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

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only





Active Ingredient (55106-9)

Active Ingredient

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

Indications and Usage (34067-9)

Use

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

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

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

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