Povidone Iodine Prep Pad

Povidone Iodine Prep Pad
SPL v3
SPL
SPL Set ID 222a1db3-d4b2-58ee-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2015-10-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (10 g)
Inactive Ingredients
Nonoxynol-9 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-10-21

Description

Povidone Iodine 10%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Povidone Iodine 10%

Uses

Antiseptic cleanser to help prevent skin infection in minor cuts, scrapes and burns.

For preparation of the skin prior to surgery

Helps reduct bacteria that can potentially cause skin infection

Section 51945-4

Section 60561-8

Store at room temperature

Avoid excessive heat

Warnings

For External Use Only

Directions

Tear at notch

Remove applicator

Use only once

As a first aid antiseptic - Clean affected area

apply 1 to 3 times daily

May be covered with a sterile bandage

If bandaged let dry first

Do Not Use

In the eyes

As a first aid antiseptic for more than 1 week

Over large areas of the body

Active Ingredient

Povidone Iodine 10%

Inactive Ingredient

nonoxynol-9, water

Stop Use and Ask Doctor If

Condition worsens or persists for more than 72 hours

Irritation and rednes develops

Ask Doctor Before Use If You Have

Deep or puncuture wounds

Animal bites

Serious wounds

Keep Out of the Reach of Children

If swallowed, get medical help or contact a Poson Control Center immediately


Structured Label Content

Uses

Antiseptic cleanser to help prevent skin infection in minor cuts, scrapes and burns.

For preparation of the skin prior to surgery

Helps reduct bacteria that can potentially cause skin infection

Section 51945-4 (51945-4)

Section 60561-8 (60561-8)

Store at room temperature

Avoid excessive heat

Purpose

Antiseptic

Warnings

For External Use Only

Directions

Tear at notch

Remove applicator

Use only once

As a first aid antiseptic - Clean affected area

apply 1 to 3 times daily

May be covered with a sterile bandage

If bandaged let dry first

Do Not Use

In the eyes

As a first aid antiseptic for more than 1 week

Over large areas of the body

Active Ingredient

Povidone Iodine 10%

Inactive Ingredient (Inactive ingredient)

nonoxynol-9, water

Stop Use and Ask Doctor If (Stop Use and ask doctor if)

Condition worsens or persists for more than 72 hours

Irritation and rednes develops

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

Deep or puncuture wounds

Animal bites

Serious wounds

Keep Out of the Reach of Children (Keep Out of the reach of Children)

If swallowed, get medical help or contact a Poson Control Center immediately


Advanced Ingredient Data


Raw Label Data

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