POVIDONE IODINE - povidone iodine solution 
James Alexander Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts

10 percent povidone iodine solution usp 1 percent available iodine topical antiseptic

topical solution usp swab to prevent infection

uses to treat minor skin cuts and abrasions

if swallowed get medical help immediately or contact a Poison Control Center right away.

For external use only.

Directions: one swab reverse cardboard sleeve then crush at dot between thumb and forefinger.  Allow solution to saturate tip and apply solution to injury.

Inactive Ingredients Citric Acid, disodium phosphate, nonoxynol 9, sodium hydroxide, water

Povidone Iodine Topical Solution USP Swabs
povidone inner label

Povidone Iodine Topical Solution USP
povidone outer label
POVIDONE IODINE 
povidone iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46414-7777
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Povidone-Iodine (UNII: 85H0HZU99M) (Povidone-Iodine - UNII:85H0HZU99M) Povidone-Iodine.006 g  in 0.6 mL
Inactive Ingredients
Ingredient NameStrength
citric acid (UNII: 2968PHW8QP)  
phosphate ion (UNII: NK08V8K8HR)  
nonoxynol-9 (UNII: 48Q180SH9T)  
sodium hydroxide (UNII: 55X04QC32I)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46414-7777-36 mL in 1 BOX
2NDC:46414-7777-260 mL in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/14/1976
Labeler - James Alexander Corporation (040756421)
Registrant - James Alexander Corporation (040756421)
Establishment
NameAddressID/FEIBusiness Operations
James Alexander Corporation040756421manufacture

Revised: 4/2011
Document Id: 4c1aec18-2099-4571-b89a-0ede65d831ff
Set id: 5b6a8391-0ae0-4e77-b325-9475a446fec4
Version: 4
Effective Time: 20110407
 
James Alexander Corporation