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

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.

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Povidone Iodine Prep Swabstick

Drug Facts

Active ingredient

Povidone lodine USP,7.5% W/V (equivalent to 0.75% titratable iodine)

Purpose

Antiseptic

Use

Warnings

For external use only.

Do not

  • use in the eyes 
  • use on individuals who are allergic or sensitive to iodine
  • apply over large areas of the body 
  • use as a first aid antiseptic longer than 1 week unless directed by a doctor. Discontinue use if irritation and redness develop. Consult a doctor in case of 
  • deep or puncture wounds
  • animal bites 
  • serious burns.

Stop use and consult a doctor

if the condition persists or gets worse.

Keep out of reach of children. 

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

Directions

For preparation of the skin prior to surgery

Other information

store at room temperature: 15°-30°C(59°-86°F)

Inactive ingredients

citric acid, purified water, sodium hydroxide, Nonoxynol-10, glycerin

Package Labeling:

Label2

POVIDONE IODINE PREP 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34645-5501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE7.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
NONOXYNOL-10 (UNII: K7O76887AP)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:34645-5501-010 in 1 CARTON02/03/2017
125 in 1 BOX
10.045 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/30/2017
Labeler - Jianerkang Medical Co., Ltd (530968767)
Establishment
NameAddressID/FEIBusiness Operations
Jianerkang Medical Co., Ltd530968767manufacture(34645-5501)

Revised: 3/2021
Document Id: beac9501-cd36-1977-e053-2a95a90a42dd
Set id: 47a504b8-b0af-030a-e054-00144ff88e88
Version: 3
Effective Time: 20210329
 
Jianerkang Medical Co., Ltd