Povidone Iodine Prep Pad

Povidone Iodine Prep Pad
SPL v6
SPL
SPL Set ID 04438f9e-302c-431b-b3ad-d2c50ca01ad8
Route
TOPICAL
Published
Effective Date 2020-03-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (0.1 g)
Inactive Ingredients
Nonoxynol-9 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-04-17

Description

Povidone Iodine 10%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Povidone Iodine 10%

Uses
  • Antiseptic cleanser to help prevent infection in minor cuts, scrapes and burns.
  • For preparation of the skin prior to surgery.
  • Helps reduce bacteria that can potentially cause skin infection.
Warnings

For External Use Only.

Directions
  • Tear at notch
  • Remove applicator
  • Use only once

As a first aid antispetic

  • Clean affected area
  • apply 1-3 times daily
  • May be covered with a sterile bandage
  • If bandaged, let dry first.

For preoperative patient skin preparation

  • Clean area
  • Apply to operative site prior to surgery using applicator

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%

Other Information
  • Store at room temperature
  • Avoid excessive heat

Inactive Ingredients

Nonoxynol-9, water

Principal Display Panel

NDC 68786-130-01

50 Packets

Povidone-Iodine Swabsticks

Antispetic/Germicide

For External Use Only

Sion Biotext Medical Ltd.

Stop Use and Ask A Doctor If
  • Condition worsens or persists for more than 72 hours
  • Irritation and redness 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
  • Antiseptic cleanser to help prevent infection in minor cuts, scrapes and burns.
  • For preparation of the skin prior to surgery.
  • Helps reduce bacteria that can potentially cause skin infection.
Purpose

Antiseptic

Warnings

For External Use Only.

Directions
  • Tear at notch
  • Remove applicator
  • Use only once

As a first aid antispetic

  • Clean affected area
  • apply 1-3 times daily
  • May be covered with a sterile bandage
  • If bandaged, let dry first.

For preoperative patient skin preparation

  • Clean area
  • Apply to operative site prior to surgery using applicator

Do Not Use (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%

Other Information
  • Store at room temperature
  • Avoid excessive heat

Inactive Ingredients

Nonoxynol-9, water

Principal Display Panel

NDC 68786-130-01

50 Packets

Povidone-Iodine Swabsticks

Antispetic/Germicide

For External Use Only

Sion Biotext Medical Ltd.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Condition worsens or persists for more than 72 hours
  • Irritation and redness 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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