POVIDONE IODINE PREP- povidone-iodine patch 
MCL Enterprises

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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Povidone-Iodine Prep Pad

Drug Facts

Active Ingredient

Povidone-Iodine 10% (w/w) (equivalent to 1 % titratable iodine)

Purpose

Antiseptic

Use:

Warnings:

Keep out of reach of children.

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

Do not use:

  • in the eyes or apply over large areas of the body 
  • longer than 1 week unless directed by a doctor 
  • on individuals who are sensitive or allergic to iodine

Stop use and ask a doctor if:

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

Directions:

Inactive Ingredient:

Purified Water

Package Labeling:

Label3

POVIDONE IODINE PREP 
povidone-iodine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71622-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71622-003-001 in 1 POUCH07/25/2017
10.45 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/25/2017
Labeler - MCL Enterprises (784754173)

Revised: 12/2017
Document Id: 616db97b-6da1-21c0-e053-2991aa0ab688
Set id: eca6e2ce-bb1e-4954-b384-753cb295c704
Version: 2
Effective Time: 20171228
 
MCL Enterprises