SPL v2
SPL
SPL Set ID f3444446-1dad-79ff-e053-2a95a90af411
Route
TOPICAL
Published
Effective Date 2023-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (5 mg)
Inactive Ingredients
Glycerin Water Citric Acid Acetate Potassium Iodate Disodium Hydrogen Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-31
Description

Povidone Iodine IP 5% w/v.

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Povidone Iodine IP 5% w/v.

Use
  • For preparation of the skin prior to surgery
  • Helps reduce bacteria that potentially can

cause skin infection

Dose
  • Clean the area and apply product to the operative site prior to surgery.
  • The solution can be used to irrigate the cornea and conjunctiva with a sterile bulb syringe prior to surgery.
  • After the solution has been left in contact for two minutes flush the residual prep solution using a sterile saline solution.
Stop Use

Irritation, sensitization, or allergic reaction

occurs and lasts for 72 hours. These may

be signs of a serious condition.

Warnings

For External use only

Questions

Call. 1-800-103-7321,

E-mail : [email protected]

Web : www.aurolab.com

Do Not Use
  • If you are allergic to povidone-iodine or

    any other ingredients in this preparation

    In the eyes
Package Carton

Active Ingredient

Povidone Iodine IP 5% w/v.

Inactive Ingredient

  • Citric acid
  • Disodium hydrogen O- phosphate, Potassium iodate
  • Glycerin
  • Purified water

Indiacations and Usage

Prolonged exposure to wet solution may

cause irritation or, rarely, severe skin

reactions

In pre-operative prepping, avoid “pooling”

beneath the patient

Keep Out of Reach of Children

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

Structured Label Content

Use (USE)
  • For preparation of the skin prior to surgery
  • Helps reduce bacteria that potentially can

cause skin infection

Dose
  • Clean the area and apply product to the operative site prior to surgery.
  • The solution can be used to irrigate the cornea and conjunctiva with a sterile bulb syringe prior to surgery.
  • After the solution has been left in contact for two minutes flush the residual prep solution using a sterile saline solution.
Purpose

Antiseptic

Stop Use (STOP USE)

Irritation, sensitization, or allergic reaction

occurs and lasts for 72 hours. These may

be signs of a serious condition.

Warnings (WARNINGS)

For External use only

Questions (QUESTIONS)

Call. 1-800-103-7321,

E-mail : [email protected]

Web : www.aurolab.com

Do Not Use (DO NOT USE)
  • If you are allergic to povidone-iodine or

    any other ingredients in this preparation

    In the eyes
Package Carton (PACKAGE CARTON)

Active Ingredient (ACTIVE INGREDIENT)

Povidone Iodine IP 5% w/v.

Inactive Ingredient (INACTIVE INGREDIENT)

  • Citric acid
  • Disodium hydrogen O- phosphate, Potassium iodate
  • Glycerin
  • Purified water

Indiacations and Usage (INDIACATIONS AND USAGE)

Prolonged exposure to wet solution may

cause irritation or, rarely, severe skin

reactions

In pre-operative prepping, avoid “pooling”

beneath the patient

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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:14.442686 · Updated: 2026-03-14T23:06:44.003626