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Povidone Iodine Impregnated by Jiangsu Province JianErKang Medical Dressing Co. ,Ltd.

Medically reviewed on March 5, 2018

Dosage form: sponge
Ingredients: POVIDONE-IODINE 7.5mg in 1mL
Labeler: Jiangsu Province JianErKang Medical Dressing Co. ,Ltd.
NDC Code: 34645-1032

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Impregnated Winged Sponges - Two Sponges Sticks Impregnated with 100ml Providone Iodine (Scrub)

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 104oF/40oC)
protect from freezing
latex free

Inactive Ingredients

purified water, hydroxyethylcellulose, Nonylph

Package Label

POVIDONE IODINE IMPREGNATED 
povidone iodine sponge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34645-1032
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE7.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) 
Packaging
#Item CodePackage Description
1NDC:34645-1032-110 POUCH in 1 BOX
1100 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/03/2015
Labeler - Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. (530968767)
Registrant - Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. (530968767)
Establishment
NameAddressID/FEIOperations
Jiangsu Province JianErKang Medical Dressing Co. ,Ltd.530968767manufacture(34645-1032)

 
Jiangsu Province JianErKang Medical Dressing Co. ,Ltd.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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