POVIDONE IODINE- povidone iodine solution 
Jianerkang Medical Co., Ltd

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Drug Facts

Active Ingredients

Povidone Iodine, USP 10% (1.0% available Iodine)

Purpose

Antiseptic

Uses

Prepping intact skin and mucous membranes prior to surgery

Warnings

For external use only

Avoid use on persons allergic to iodine

Stop use and ask a doctor if

Skin shows symptoms of irritation, sensitivity, redness, pain or swelling

Keep out of reach of children

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

Directions

Patient preoperative prep

use full strength

apply solution to operative site following povidone iodine scrub application

using a circular motion, start at incision site and move outward

remove all soiled underdrapes

do not allow solution to pool


Other information

store at room temperature avoid excessive heat (above 104oF/40oC) protect from freezing latex free


Inactive Ingredients

Citric Acid, Glycerin, Nonoxynol - 10, Purified Water, Sodium hydroxide, hydroxyethylcellulose

Package Label

Pouch Label

POVIDONE IODINE 
povidone iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34645-4188
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
NONOXYNOL-10 (UNII: K7O76887AP)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:34645-4188-688.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00501/01/2010
Labeler - Jianerkang Medical Co., Ltd (530968767)

Revised: 10/2023
Document Id: 085bc532-b22e-8f18-e063-6394a90a03ae
Set id: 0bd3de76-b726-41f1-87bc-14ab8a1eca8e
Version: 6
Effective Time: 20231023
 
Jianerkang Medical Co., Ltd