MedPride Prep Solution
Medpride Prep Solution Topical Antiseptic Microbicide
Approved
Approval ID
88cb1b8d-3dae-be00-e053-2995a90a0d11
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Aug 18, 2025
Manufacturers
FDA
Shield Line LLC
DUNS: 078518916
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
POVIDONE-IODINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52410-4114
Application NumberM003
Product Classification
M
Marketing Category
C200263
G
Generic Name
POVIDONE-IODINE
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 18, 2025
FDA Product Classification
INGREDIENTS (7)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POVIDONE-IODINEActive
Quantity: 100 mg in 1 mL
Code: 85H0HZU99M
Classification: ACTIM
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 5/13/2019
Principal Display Panel
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 5/13/2019
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
OTC - ASK DOCTOR SECTION
LOINC: 50569-3Updated: 5/13/2019
Ask your doctor in case of
- Deep or puncture wounds
- Animal bites
- Serious burns
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 5/13/2019
Active Ingredient
Povidone Iodine, 10% (equivalent to 1% available Iodine)
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 5/13/2019
Purpose
Antiseptic
WARNINGS SECTION
LOINC: 34071-1Updated: 5/13/2019
Warnings
For External Use Only
OTC - DO NOT USE SECTION
LOINC: 50570-1Updated: 5/13/2019
Do not use
- 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
OTC - STOP USE SECTION
LOINC: 50566-9Updated: 5/13/2019
Discontinue use and call your doctor if
- Irritation and redness develop and persists for more than 72 hours
- Condition persists or get worse
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
LOINC: 50565-1Updated: 5/13/2019
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 5/13/2019
Directions
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 INGREDIENT SECTION
LOINC: 51727-6Updated: 5/13/2019
Inactive ingredients
Citric Acid, Sodium Citrate, Glycerin, Tween 80, Disodium Phosphate, Purified Water