POVIDONE IODINE - povidone-iodine solution 
Supervalu Inc

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% w/v (equivalent to 1% titratable iodine)

PURPOSE

Antiseptic

USE

First aid antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns

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

Discontinue use and ask a doctor

  • if condition persists or gets worse
  • for use longer than 1 week



Ask a doctor in case of

  • deep or puncture wounds
  • animal bites
  • serious burns



Keep out of reach of children

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

DIRECTIONS


OTHER INFORMATION

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

INACTIVE INGREDIENTS

citric acid, glycerin, Makon 8, purified water, sodium hydroxide


LABEL INFORMATION

EQUALINE

*Compare to Betadine active ingredient®

NDC 24385-053-55

Topical Antiseptic Solution

10% povidone-iodine solution, USP
topical antiseptic

helps reduce bacteria that can potentially cause skin infection

NET WT 8 FL OZ (236 mL)

*This product is not manufactured of distributed by Purdue Frederick, owner of the registered trademark, Betadine®.

Distributed by Albertsons, Inc.
Boise, Idaho 83726

We're committed to your satisfaction and guarantee the quality of this product. Contact us at 1-877-932-7948 or www.albertsons.com.

label

POVIDONE IODINE 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-052
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
povidone-iodine (UNII: 85H0HZU99M) (povidone-iodine - UNII:85H0HZU99M) povidone-iodine0.10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
citric acid monohydrate (UNII: 2968PHW8QP)  
glycerin (UNII: PDC6A3C0OX)  
sodium hydroxide (UNII: 55X04QC32I)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41163-052-55236 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/01/2004
Labeler - Supervalu Inc (006961411)

Revised: 2/2010
Document Id: 1eee11ca-a817-4ecb-bbd9-cb34a8c47a85
Set id: 0b86b64b-dc81-4e12-9862-b3700edd3d2b
Version: 1
Effective Time: 20100202
 
Supervalu Inc