Pvp-i

Pvp-i
SPL v12
SPL
SPL Set ID 50c524ab-7029-494a-8bb4-d90a4d184fb2
Route
TOPICAL
Published
Effective Date 2015-02-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (10 mg)
Inactive Ingredients
Water Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1978-01-01 Until 2026-07-03
Description

Povidone-Iodine USP 10% w/w (equivalent to 1.0% titratable iodine)

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Povidone-Iodine USP 10% w/w (equivalent to 1.0% titratable iodine)

Uses
  • A broad spectrum antiseptic for topical application for preparation of the skin prior to surgery.
Warnings

For external use only

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

Discontinue use if irritation and redness develop. If condition persist for more than 72 hours or gets worse, consult a healthcare provider

Directions

For preparation of the skin prior to surgery

  • clean the treatment area
  • remove swab
  • apply to the operative site prior to surgery
  • allow to dry

Do Not Use

Do not use

- in the eyes, nose or mouth

- on individuals who are allergic or sensitive to iodine

- over large areas of the body

- longer than one week unless directed by a doctor

Active Ingredient

Povidone-Iodine USP 10% w/w (equivalent to 1.0% titratable iodine)

Other Information
  • Store at room temperature
  • Avoid excessive heat
Inactive Ingredients

Purified Water, Sodium Hydroxide

Principal Display Panel

Packet 1 swabstick

Box 1 swabstick

Packet 3 swabsticks

Box 3 swabsticks

Packet med

Box med

Consult A Healthcare Provider

Consult a healthcare provider in case of

- deep or puncture wounds

- animal bites

- serious burns

Keep Out of Reach of Children

Keep out of reach of children.

Structured Label Content

Uses
  • A broad spectrum antiseptic for topical application for preparation of the skin prior to surgery.
Purpose

Antiseptic

Warnings

For external use only

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

Discontinue use if irritation and redness develop. If condition persist for more than 72 hours or gets worse, consult a healthcare provider

Directions

For preparation of the skin prior to surgery

  • clean the treatment area
  • remove swab
  • apply to the operative site prior to surgery
  • allow to dry

Do Not Use (Do not use)

Do not use

- in the eyes, nose or mouth

- on individuals who are allergic or sensitive to iodine

- over large areas of the body

- longer than one week unless directed by a doctor

Active Ingredient (Active ingredient)

Povidone-Iodine USP 10% w/w (equivalent to 1.0% titratable iodine)

Other Information (Other information)
  • Store at room temperature
  • Avoid excessive heat
Inactive Ingredients (Inactive ingredients)

Purified Water, Sodium Hydroxide

Principal Display Panel

Packet 1 swabstick

Box 1 swabstick

Packet 3 swabsticks

Box 3 swabsticks

Packet med

Box med

Consult A Healthcare Provider (Consult a healthcare provider)

Consult a healthcare provider in case of

- deep or puncture wounds

- animal bites

- serious burns

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

Keep out of reach of children.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:13.203130 · Updated: 2026-03-14T23:12:58.166895