SPL v5
SPL
SPL Set ID 4777b5f4-1698-08da-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2017-01-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-01-17

Description

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


Medication Information

Warnings and Precautions

For external use only.

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

Discontinue use ifirritation and redness develop

Consult a doctor in case of• deep or puncture wounds • animal bites • serious burns

Stop use and consult a doctorif the condition persists or gets worse

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.

Dosage and Administration

For preparation of the skin prior to surgery• clean the affected area • remove swab by stick • apply to the operative site prior to surgery

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

Description

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 51727-6

Citric Acid, Sodium Hydroxide, Nonoxynol-10, Glycerin, Water.

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

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

Section 60561-8

Store at 59-86ºF (15-30ºC).


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.

Dosage and Administration (34068-7)

For preparation of the skin prior to surgery• clean the affected area • remove swab by stick • apply to the operative site prior to surgery

For use as a first aid antiseptic• clean the affected area • apply a small amount of this product on the area 1 - 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 or apply• in the eyes • on individuals who are allergic or sensitive to iodine • over large areas of the body • as a first aid antiseptic longer than 1 week unless directed by a doctor

Discontinue use ifirritation and redness develop

Consult a doctor in case of• deep or puncture wounds • animal bites • serious burns

Stop use and consult a doctorif the condition persists or gets worse

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 51727-6 (51727-6)

Citric Acid, Sodium Hydroxide, Nonoxynol-10, Glycerin, Water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

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

Section 60561-8 (60561-8)

Store at 59-86ºF (15-30ºC).


Advanced Ingredient Data


Raw Label Data

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