POVIDONE-IODINE- povidone-iodine ointment 
Qualitest Pharmaceuticals

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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Povidone-Iodine Ointment 10%
Maximum Strength

Active ingredient

Povidone-iodine 10% - equal to 1% available iodine

Purpose

First aid antiseptic

Uses

first aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns

Warnings

For external use only

Do not use

  • if you are sensitive to iodine or other product ingredients
  • in the eyes
  • for longer than one week unless directed by a doctor
  • over large areas of the body

Ask a doctor before use if you have

  • deep or puncture wounds
  • serious burns
  • animal bites

Stop use and ask a doctor if

  • redness, irritation, swelling or pain continues or increases
  • infection occurs

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 on the area 1 to 3 times daily
  • may be covered with a sterile bandage

Other information

  • avoid storing at excessive heat
  • lot number and expiration date: see crimp of tube or box
  • to open: unscrew cap, use pointed end on cap to puncture seal

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

polyethylene glycols

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 5/15 R4
8280780 0599

PRINCIPAL DISPLAY PANEL

This is an image of the Povidone-Iodine Ointment 10% carton.
POVIDONE-IODINE 
povidone-iodine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-0599
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0603-0599-501 in 1 CARTON08/01/199703/15/2018
128.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333A08/01/199703/15/2018
Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
NameAddressID/FEIBusiness Operations
Vintage Pharmaceuticals-Huntsville825839835MANUFACTURE(0603-0599)

Revised: 8/2015
 
Qualitest Pharmaceuticals