POVIDONE-IODINE PREP- povidone-iodine patch 
Yinjing Medical Technology (Shanghai) Co., Ltd.

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

Drug Facts

Active ingredient

Povidon-Iodin 10% (w/w)

(equivalent to 1% titratable iodine)

Purpose

Antiseptic

Uses

Warnings

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

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

Keep out of reach of children.

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

Directions

Inactive ingredient

Other information

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POVIDONE-IODINE PREP 
povidone-iodine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44019-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44019-100-001 in 1 POUCH07/07/2017
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 finalpart333A07/07/2017
Labeler - Yinjing Medical Technology (Shanghai) Co., Ltd. (530501535)

Revised: 12/2017
Document Id: 616db8a9-6108-ed9a-e053-2a91aa0a32c7
Set id: 2211daa1-41f3-4be5-a309-6390d0883561
Version: 3
Effective Time: 20171228
 
Yinjing Medical Technology (Shanghai) Co., Ltd.