MEDPRIDE PREP SOLUTION TOPICAL ANTISEPTIC MICROBICIDE- povidone-iodine solution 
Shield Line LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Medpride Prep Solution Topical Antiseptic Microbicide

Active Ingredient

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

Purpose

Antiseptic

Uses

Warnings

For External Use Only

Do not use

Discontinue use and call your doctor if

Ask your doctor in case of

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:

As a first aid antiseptic:

Inactive ingredients

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

Principal Display Panel

Principal Display & Drug Fact PanelPrincipal Display & Drug Fact Panel package 2

MEDPRIDE PREP SOLUTION  TOPICAL ANTISEPTIC MICROBICIDE
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52410-4114
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52410-4114-5474 mL in 1 BOTTLE; Type 0: Not a Combination Product05/13/2019
2NDC:52410-4114-63785 mL in 1 JUG; Type 0: Not a Combination Product05/13/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/13/2019
Labeler - Shield Line LLC (078518916)

Revised: 4/2023
Document Id: f901c56b-d6a5-a800-e053-6394a90ad2cd
Set id: 88cb1b8d-3dae-be00-e053-2995a90a0d11
Version: 2
Effective Time: 20230410
 
Shield Line LLC