943 PVP Prep Solution

Manufacturer
Medline Industries, LP
Effective date
2022-12-15
Label type
HUMAN OTC DRUG LABEL
Version
4
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

■ Healthcare antiseptic for preparation of the skin prior to surgery ■ First aid antiseptic to help prevent infection in minor cuts, scrapes and burns

Dosage and administration

Clean the affected area For preparation of the skin prior to surgery: apply product to the operative site prior to surgery For first aid antiseptic: apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

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, 10%

(equivalent to 1% available iodine)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

■ Healthcare antiseptic for preparation of the skin prior to surgery

■ First aid antiseptic to help prevent infection in minor cuts, scrapes and burns

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

■ in the eyes

■ longer than 1 week unless directed by a doctor

■ on individuals who are allergic or sensitive to iodine

■ or apply over large areas of the body

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if irritation and redness develop
  • if condition persists for more than 72 hours
  • in case of deep or puncture wounds, animal bites or serious burns

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

Clean the affected area

  • For preparation of the skin prior to surgery: apply product to the operative site prior to surgery
  • For first aid antiseptic: apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Other Information

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Disodium Phosphate, Glycerin, Nonylphenol 9, Purified Water, Sodium Citrate

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: 503911
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 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-94353329-943-69, 53329-943-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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
28f182f4-7a2b-6528-e063-6294a90a9c2a42775923-a343-6149-e054-00144ff8d46c2024-12-10WarningsExact identifier
spl set id: 42775923-a343-6149-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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