POVIDONE-IODINE SOLUTION STERILE- povidone-iodine liquid 
Changzhou Maokang Medical Products Co., Ltd

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Povidone-Iodine Solution Sterile

Drug Facts

Active ingredient

Povidone-Iodine 10%USP

Purpose

First aid antiseptic

Use

for antiseptic skin preparation

Warnings

do not use

  • if allergic to Iodine
  • 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 reavh 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 punture wounds
  • serious burns

Directions

Apply product to skin as needed.

Other information

Inactive ingredients:

Citric Acid,Alkyl Glucoside,Hydroxyethyl cellulose,Nonoxynol-10,Glycerin,Sodium Hydroxide,Potassium Iodide, Purified Water.

Package Labeling:

Label

POVIDONE-IODINE SOLUTION STERILE 
povidone-iodine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59050-554
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
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:59050-554-1130 mL in 1 POUCH; Type 0: Not a Combination Product10/22/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)10/22/2019
Labeler - Changzhou Maokang Medical Products Co., Ltd (421317073)
Establishment
NameAddressID/FEIBusiness Operations
Changzhou Maokang Medical Products Co., Ltd421317073manufacture(59050-554)

Revised: 11/2023
Document Id: 09c712f0-9404-428b-e063-6394a90ad096
Set id: 478e9d3c-42ff-4ccc-8dd8-6f690cd629d7
Version: 3
Effective Time: 20231110
 
Changzhou Maokang Medical Products Co., Ltd