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

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Impregnated Winged Sponges - Four Large Winged Sponges Impregnated with 100ml Providone Iodine Cleansing Solution (Paint)

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

open pouch at tear notch

use sponge sticks to prep desired area

Other information

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


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Inactive Ingredients

purified water, hydroxyethylcellulose, Nonylph

Package Label

label1

POVIDONE IODINE IMPREGNATED 
povidone iodine sponge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34645-1028
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
WATER (UNII: 059QF0KO0R)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:34645-1028-110 in 1 BOX09/10/2015
1100 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)09/10/2015
Labeler - Jianerkang Medical Co., Ltd (530968767)
Establishment
NameAddressID/FEIBusiness Operations
Jianerkang Medical Co., Ltd530968767manufacture(34645-1028)

Revised: 10/2023
Document Id: 085cf04e-cf69-92d5-e063-6394a90a2d9a
Set id: ccf3b4c4-2c33-4fae-9916-1149d40c7876
Version: 4
Effective Time: 20231023
 
Jianerkang Medical Co., Ltd