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

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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 DrugM00301/30/2017
Labeler - Jianerkang Medical Co., Ltd (530968767)
Establishment
NameAddressID/FEIBusiness Operations
Jianerkang Medical Co., Ltd530968767manufacture(34645-5501)

Revised: 10/2023
Document Id: 085c75f1-c9c9-cbb2-e063-6294a90a07c2
Set id: 47a504b8-b0af-030a-e054-00144ff88e88
Version: 4
Effective Time: 20231023
 
Jianerkang Medical Co., Ltd