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

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Drug Facts

Active Ingredients

Povidone Iodine, USP 7.5% (0.75% available Iodine)

Purpose

Antiseptic

Uses

For preparation of 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 saturated sponge to operative site

scrub in circular motion for 5 minutes starting at incision site and move outward

blot with sterile towel

follow with application of topical solution


Other information

store at room temperature avoid excessive heat (above104oF/40oC) protect from freezing latex free


Inactive Ingredients

alkyl polyglucoside, citric acid, nonoxynol - 10, purified water, sodium hydroxide

Package label

Pouch Label

POVIDONE IODINE 
povidone iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34645-4009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE7.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
NONOXYNOL-10 (UNII: K7O76887AP)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:34645-4009-6109 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)
Establishment
NameAddressID/FEIBusiness Operations
Jianerkang Medical Co., Ltd530968767manufacture(34645-4009)

Revised: 10/2023
Document Id: 085b3032-f1ad-4f71-e063-6294a90a1c05
Set id: e1789944-3a41-4c86-b173-3a6993ae2141
Version: 6
Effective Time: 20231023
 
Jianerkang Medical Co., Ltd