Drug Fact

Drug Fact
SPL v6
SPL
SPL Set ID 2fefe844-09a3-4ebe-b4ab-930ae6ecc618
Route
TOPICAL
Published
Effective Date 2014-03-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (0.1 mg)
Inactive Ingredients
Water Nonoxynol-10

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-03-28

Description

Povidone Iodine 10%

Purpose

First Aid Antiseptic


Medication Information

Purpose

First Aid Antiseptic

Description

Povidone Iodine 10%

Use

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

Dosage

SWAB

Warning

For external use only.

Do Not Use

● use in the eyes

●apply over large areas of the body

● use on individuals who are allergic or sensitive to iodine

Active Ingredient

Povidone Iodine 10%

Image of Pouch Label

Inactive Ingredient 

Nonoxynol-10, Purified water

Keep Out of Reach of Children

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

Stop Use and Consult A Doctor

●if the condition persists or gets worse

● for use longer than 1 week. Ask a doctor in case of deep or puncture wounds, animal bites, serious burns


Structured Label Content

Use

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

Dosage

SWAB

Purpose

First Aid Antiseptic

Warning

For external use only.

Do Not Use

● use in the eyes

●apply over large areas of the body

● use on individuals who are allergic or sensitive to iodine

Active Ingredient

Povidone Iodine 10%

Image of Pouch Label

Inactive Ingredient 

Nonoxynol-10, Purified water

Keep Out of Reach of Children (Keep out of reach of children)

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

Stop Use and Consult A Doctor (Stop Use and Consult a Doctor)

●if the condition persists or gets worse

● for use longer than 1 week. Ask a doctor in case of deep or puncture wounds, animal bites, serious burns


Advanced Ingredient Data


Raw Label Data

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