POVIDONE IODINE PREP- povidone iodine solution 
Cardinal Health

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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Drug Facts

Active ingredient

Povidone Iodine 10%

(equivalent to 1% titratable iodine)


Purpose

Antiseptic/First Aid Antispetic


Uses

Warnings

For External Use Only.


Do not use

As a first aid antiseptic



  • Do not use in the eyes or apply over large areas of the body
  • In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor
  • Stop use and consult a doctor if the condition persists or gets worse
  • Do not use longer than 1 week unless directed by a doctor

For preoperative patient skin preparation



  • Do not use in the eyes
  • Discontinue use if irritation and redness develop
  • If condition persists for more than 72 hours, consult a doctor



Keep out of reach of children.

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

Directions:

Clean the affected area.



For preparation of skin prior to surgery

For first aid antiseptic




Other information


Inactive Ingredients:

Citric Acid, Disodium Phosphate, Nonoxynol-9, Sodium Hydroxide, Water


Principal Display Panel

Povidone-Iodine Prep Solution

Povidone-Iodine 10%

single use only

Cardinal Health

Net Wt. 0.75 fl oz (22.2 mL)

NDC 63517-132-01



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POVIDONE IODINE PREP 
povidone iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63517-132
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63517-132-01500 in 1 CASE08/25/2016
122.2 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C08/26/2015
Labeler - Cardinal Health (961027315)

Revised: 12/2022
Document Id: efa7cf4e-3b08-7b59-e053-2a95a90ab9cd
Set id: 4c47327a-3d31-4cf3-ae81-6a20976197fb
Version: 3
Effective Time: 20221212
 
Cardinal Health