DRUG FACTS

DRUG FACTS

Drug Labeling and Warnings

Drug Details

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POVIDONE IODINE - povidone-iodine solution 
Amerisource Bergen

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

  • Clean the affected area
  • Apply a small amount of this product to the area 1-3 times daily
  • May be covered with a sterile bandage
  • If bandaged, let dry first


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

NDC: 24385-053-55

GOOD NEIGHBOR PHARMACY

povidone iodine, 10% solution

*Compare to active ingredient in BETADINE®

Topical antiseptic

Helps prevent infection in minor cuts, scrapes, and burns

  • Use for first aid and general hygiene
  • Helps reduce bacteria that can potentially cause skin infection
  • Water soluble

8 fl. oz. (236 mL)

Distributed By
AmerisourceBergen
Valley Forge, PA 19482-0959
Visit us at www.myGNP.com

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

label



POVIDONE IODINE 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 24385-053
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
povidone-iodine (UNII: 85H0HZU99M) (povidone-iodine - UNII:85H0HZU99M) povidone-iodine.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: 24385-053-55236 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/01/2005
Labeler - Amerisource Bergen (007914906)

Revised: 1/2010
 
Amerisource Bergen


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