FDA.reportPublic FDA data

MedPride Prep Solution

Manufacturer
Shield Line LLC
Effective date
2025-08-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:11:16

Label at a glance#

ProductMedPride Prep Solution Topical Antiseptic Microbicide
Active ingredientPOVIDONE-IODINE
Label structure11 sections

Indications and uses

Health-care 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

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

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

  • Health-care 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 eyes
  • As a first antiseptic longer than one week
  • On individuals who are allergic or sensitive to iodine
  • Apply over large areas of body

Discontinue use and call your doctor if

OTC - STOP USE SECTION

  • Irritation and redness develop and persists for more than 72 hours
  • Condition persists or get worse

Ask your doctor in case of

OTC - ASK DOCTOR SECTION

  • Deep or puncture wounds
  • Animal bites
  • 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For preparation of the skin prior to surgery:

  • Apply product to the operative site prior to surgery

As a first aid antiseptic:

  • Clean the affected area
  • Apply a small amount of this product on the area 1-3 times daily
  • May be covered with a sterile bandage
  • If bandaged, let dry first

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Sodium Citrate, Glycerin, Tween 80, Disodium Phosphate, Purified Water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug FactDrug Fact

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312564povidone-iodine 10 % Topical SolutionPSN3
312564povidone-iodine 100 MG/ML Topical SolutionSCD3
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52410-4114-52025-08-20C16284748780-1ba0f9c33-11bb-a910-e053-dadaa90a0b85Medpride Prep Solution Topical Antiseptic Microbicide
52410-4114-62025-08-20C16284748780-1ba0f9c33-11bb-a910-e053-dadaa90a0b85Medpride Prep Solution Topical Antiseptic Microbicide
52410-4114-52025-01-30C16284748780-1ba0f9c33-11bb-a910-e053-dadaa90a0b85Medpride Prep Solution Topical Antiseptic Microbicide
52410-4114-62025-01-30C16284748780-1ba0f9c33-11bb-a910-e053-dadaa90a0b85Medpride Prep Solution Topical Antiseptic Microbicide
52410-4114-52023-04-10C16284748780-1ba0f9c33-11bb-a910-e053-dadaa90a0b85Medpride Prep Solution Topical Antiseptic Microbicide
52410-4114-62023-04-10C16284748780-1ba0f9c33-11bb-a910-e053-dadaa90a0b85Medpride Prep Solution Topical Antiseptic Microbicide
52410-4114-52021-01-29C16284748780-1ba0f9c33-11bb-a910-e053-dadaa90a0b85Medpride Prep Solution Topical Antiseptic Microbicide
52410-4114-62021-01-29C16284748780-1ba0f9c33-11bb-a910-e053-dadaa90a0b85Medpride Prep Solution Topical Antiseptic Microbicide

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52410-4114-5MedPride Prep SolutionTopical Antiseptic Microbicide474 mL in 1 BOTTLESOLUTION4743
52410-4114-6MedPride Prep SolutionTopical Antiseptic Microbicide3785 mL in 1 JUGSOLUTION37853

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52410-411452410-4114-5, 52410-4114-6

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 806OZP39ZG8HIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
WATER059QF0KO0RIACT
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
MedPride Prep Solution Topical Antiseptic MicrobicidePOVIDONE-IODINEShield Line LLC88cb1b8d-3dae-be00-e053-2995a90a0d112025-08-18WarningsExact identifier
ndc (package): 52410-4114-6
ndc (package): 52410-4114-5
ndc (product): 52410-4114
ndc11 (package): 52410411405
ndc11 (package): 52410411406
spl id: 3ca77a9f-3ec8-5f67-e063-6294a90a37d5
spl set id: 88cb1b8d-3dae-be00-e053-2995a90a0d11

Reported adverse events (FAERS/openFDA)#

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