POVIDONE IODINE IMPREGNATED- povidone iodine sponge 
Jianerkang Medical Co., Ltd

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Drug Facts

Active Ingredients

Povidone Iodine, USP 10% (1.0% 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

open pouch at tear notch

use sponge sticks to prep desired area

Other information

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


Inactive Ingredients

hydroxyethylcellulose, nonoxynol - 10, purified water

Package Labeling

image description

POVIDONE IODINE IMPREGNATED 
povidone iodine sponge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34645-4010
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
NONOXYNOL-10 (UNII: K7O76887AP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:34645-4010-4100 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)01/01/2010
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(34645-4010)

Revised: 10/2023
Document Id: 085ba045-3c6d-fb30-e063-6394a90a3491
Set id: 14f2a1dd-92c2-49e8-9fa0-a9d88e8c530d
Version: 6
Effective Time: 20231023
 
Jianerkang Medical Co., Ltd