drug facts

drug facts
SPL v5
SPL
SPL Set ID e05af551-647d-4278-bb7f-86f888ddbb8b
Route
topical
Published
Effective Date 2015-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
iodine (1 g)
Inactive Ingredients
sodium citrate polysorbate 80 glycerin sodium phosphate, dibasic, unspecified form citric acid nonoxynol-9 water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2015-07-16
Purpose

Antiseptic

Description

Povidone Iodine  10% w/v

Medication Information

Uses


  • Antiseptic cleanser to help prevent skin 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

Other Information
  • Store at room temperature
  • Avoid excessive heat



Description

Povidone Iodine  10% w/v

Principal Display Panel

PVP Prep Solution

First Aid Antiseptic

NET WT. 0.75 oz

500 Packets per Case

Made in Israel

NDC 68786-132-01

100 Packets per case

NDC 68786-132-02







Warnings:

For External Use Only.



Do Not Use
  • In the eyes
  • As a first aid antiseptic for more than 1 week
  • Over large areas of the body




Directions:
  • Tear at notch
  • 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.


For preoperative patient skin preparation

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







Active Ingredient

Povidone Iodine  10% w/v

Inactive Ingredients:
  • Nonoxynol-9, water



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 immediately.


Ask A Doctor Before Use If You Have
  • Deep or puncture wounds
  • Animal bites
  • Serious wounds

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 reduce bacteria that can potentially cause skin infection

Purpose

Antiseptic

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



Principal Display Panel

PVP Prep Solution

First Aid Antiseptic

NET WT. 0.75 oz

500 Packets per Case

Made in Israel

NDC 68786-132-01

100 Packets per case

NDC 68786-132-02







Warnings:

For External Use Only.



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




Directions:
  • Tear at notch
  • 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.


For preoperative patient skin preparation

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







Active Ingredient (Active ingredient)

Povidone Iodine  10% w/v

Inactive Ingredients:
  • Nonoxynol-9, water



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 immediately.


Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • Deep or puncture wounds
  • Animal bites
  • Serious wounds

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:56.447043 · Updated: 2026-03-14T23:10:01.237919