MEDPRIDE PREP SOLUTION TOPICAL ANTISEPTIC MICROBICIDE- povidone-iodine solution

MedPride Prep Solution by

Drug Labeling and Warnings

MedPride Prep Solution by is a Otc medication manufactured, distributed, or labeled by Shield Line LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Povidone Iodine, 10% (equivalent to 1% available Iodine)

Purpose

Antiseptic

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

Warnings

For External Use Only

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

Discontinue use and call your doctor if

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

Ask your doctor in case of

• Deep or puncture wounds
• Animal bites
• Serious burns

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

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 ingredients

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

Principal Display Panel

INGREDIENTS AND APPEARANCE

MEDPRIDE PREP SOLUTION  TOPICAL ANTISEPTIC MICROBICIDE
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52410-4114
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52410-4114-5	474 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/13/2019
2	NDC: 52410-4114-6	3785 mL in 1 JUG; Type 0: Not a Combination Product	05/13/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/13/2019

Labeler - Shield Line LLC (078518916)