NON-STERILE- povidone-iodine patch 
Changzhou Maokang Medical Products 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 Solution, Non-sterile

Drug Facts

Active ingredient

Povidone-lodine 10%w/w

Purpose

Antiseptic

Use

for antiseptic skin preparation

Warnings

do not use

  • if allergic to lodine
  • do not use in the eye

Stop use and ask a doctor if

  • redness, irritation, swelling or pain persists or increases
  • infection occurs

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Avoid pooling beneath patient.

Ask a doctor before use if injuries are

  • deep or puncture wounds
  • serious burns

Driections

apply locally as needed

Other information

Inactive ingredients:

Citrc Acid, Alkyl Glucoside, Hydroxyethy, Cellulose, Nonoxynol-10, Glycerin, Sodium Hydroxide, Potassium lodide, Purifed Water.

Package Labeling:

Label

NON-STERILE 
povidone-iodine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59050-553
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
NONOXYNOL-10 (UNII: K7O76887AP)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
POTASSIUM IODIDE (UNII: 1C4QK22F9J)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59050-553-1122.5 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/29/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/29/2018
Labeler - Changzhou Maokang Medical Products Co., Ltd (421317073)
Establishment
NameAddressID/FEIBusiness Operations
Changzhou Maokang Medical Products Co., Ltd421317073manufacture(59050-553)

Revised: 9/2018
Document Id: 75b06e94-8227-dc0d-e053-2991aa0a8454
Set id: 123e147b-ad97-4f46-8291-cebda20a712f
Version: 1
Effective Time: 20180912
 
Changzhou Maokang Medical Products Co., Ltd