FDA.reportPublic FDA data

944 PVP Scrub Solution

Manufacturer
Medline Industries, LP
Effective date
2022-12-15
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:44:13

Label at a glance#

ProductPovidone-Iodine
Active ingredientPOVIDONE-IODINE
Label structure9 sections

Indications and uses

For preparation of the skin prior to surgery helps to reduce bacteria that potentially can cause skin infection significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care

Dosage and administration

Surgical Hand Scrub: Clean under nails with a nail pick. Nails should be maintained with a 1 millimeter free edge. Wet hands and forearms Apply 5 milliliters (teaspoonful) or palmful to hands and forearms Scrub thoroughly for about 5 minutes paying particular attention to the nails, cuticles, and interdigital spaces Use a sterile scrub brush, if desired Rinse and repeat scrub Patient Pre-operative Skin Preparation...

Storage and handling

Store at Room Temperature. Protect from freezing. Avoid excessive heat.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-Iodine, 7.5%

(equivalent to 0.75% available iodine)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • For preparation of the skin prior to surgery
  • helps to reduce bacteria that potentially can cause skin infection
  • significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • in the eyes
  • if you are allergic to iodine or any of the other ingredients in the product.

When using this product

OTC - WHEN USING SECTION

  • prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions
  • in pre-operative prepping, avoid “pooling” beneath the patient.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if irritation and redness develop
  • if condition persists for more than 72 hours

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Surgical Hand Scrub:

  • Clean under nails with a nail pick. Nails should be maintained with a 1 millimeter free edge.
  • Wet hands and forearms
  • Apply 5 milliliters (teaspoonful) or palmful to hands and forearms
  • Scrub thoroughly for about 5 minutes paying particular attention to the nails, cuticles, and interdigital spaces
  • Use a sterile scrub brush, if desired
  • Rinse and repeat scrub

Patient Pre-operative Skin Preparation:

  • Prior to surgery, wet skin with water
  • Apply scrub to the operative site
  • scrub thoroughly for about 5 minutes
  • Rinse using sterile gauze or towel, or remove with 70 percent alcohol
  • follow with application of Medline Prep Solution and allow to dry

Other Information

STORAGE AND HANDLING SECTION

Store at Room Temperature. Protect from freezing. Avoid excessive heat.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Disodium Phosphate, Glycerin, Hydroxy Ethyl Cellulose, Monoethanolamine, Water

Manufacturing Information

SPL UNCLASSIFIED SECTION

Manufactured for:
Medline Industries, LP
Three Lakes Drive, Northfield, IL 60093 USA
Made in Mexico
www.medline.com
1-800-MEDLINE (633-5463)
REF: 500762
V1 RK22DEG

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label V1 RK22DEGLabel V1 RK22DEG

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-94453329-944-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
GLYCERINPDC6A3C0OXIACT
MONOETHANOLAMINE5KV86114PTIACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT
POVIDONE-IODINE85H0HZU99MACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2929907a-bbeb-b0ee-e063-6394a90a491b4275ce04-650f-01f2-e054-00144ff88e882024-12-13WarningsExact identifier
spl set id: 4275ce04-650f-01f2-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.