Drug Facts

Drug Facts
SPL v10
SPL
SPL Set ID 289e92a2-f03f-4b8a-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (0.1 g)
Inactive Ingredients
Citric Acid Monohydrate Water Sodium Phosphate, Dibasic

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-10-20

Description

Povidone Iodine 10% v/v (equivalent to 1% titratable iodine)

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Povidone Iodine 10% v/v (equivalent to 1% titratable iodine)

Uses

■ 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

Warnings

For external use only

Directions

■ for preparation of the skin prior to surgery, clean the affected area, remove the pad, 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

Do Not Use

■ in the eyes

■ on individuals who are allergic or sensitive to iodine

over large areas of the body

■ as first aid antiseptic for more than 1 week unless directed by doctor

Package Label

Active Ingredient

Povidone Iodine 10% v/v

(equivalent to 1% titratable iodine)

Other Information

■ store at room temperature:15-30C (59-86F)

Inactive Ingredients

Citric Acid Monohydrate, Sodium Phosphate Dibasic, Water

Stop Use and Ask A Doctor If

■ condition worsens or persists fro more than 72 hours ■ irritation and rednesss develops

Keep Out of Reach of Children

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

Ask A Doctor Before Use If You Have

■ deep or puncture wounds

animal bites

■ serious burns


Structured Label Content

Uses

■ 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

Purpose

Antiseptic

Warnings

For external use only

Directions

■ for preparation of the skin prior to surgery, clean the affected area, remove the pad, 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

Do Not Use (Do not use)

■ in the eyes

■ on individuals who are allergic or sensitive to iodine

over large areas of the body

■ as first aid antiseptic for more than 1 week unless directed by doctor

Package Label

Active Ingredient

Povidone Iodine 10% v/v

(equivalent to 1% titratable iodine)

Other Information

■ store at room temperature:15-30C (59-86F)

Inactive Ingredients

Citric Acid Monohydrate, Sodium Phosphate Dibasic, Water

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ condition worsens or persists fro more than 72 hours ■ irritation and rednesss develops

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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

■ deep or puncture wounds

animal bites

■ serious burns


Advanced Ingredient Data


Raw Label Data

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