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Povidone Iodine Prep by MCL Enterprises

Medically reviewed on Dec 28, 2017

Dosage form: patch
Ingredients: POVIDONE-IODINE 100mg in 1g
Labeler: MCL Enterprises
NDC Code: 71622-003

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.

Povidone-Iodine Prep Pad

Drug Facts

Active Ingredient

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

Purpose

Antiseptic

Use:
  • For preparation of the skin prior to surgery 
  • First aid antiseptic to help prevent infection in scrapes, minor cuts and burns

Warnings:
  • For external use only

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:
  • Clean the treatment area
  • Apply a small amout of this product on the area 1~3 times daily 
  • may be covered with a sterile bandage
  • if bandaged, let dry first

Inactive Ingredient:

Purified Water

Package Labeling:

POVIDONE IODINE PREP 
povidone-iodine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71622-003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage Description
1NDC:71622-003-001 PATCH in 1 POUCH
10.45 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/25/2017
Labeler - MCL Enterprises (784754173)

 
MCL Enterprises

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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