Your browser does not support JavaScript! POVIDONE IODINE SOLUTION [QUALITEST PHARMACEUTICALS]
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POVIDONE IODINE solution
[Qualitest Pharmaceuticals]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active ingredient

Povidone-iodine, 10%

(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

  • in the eyes
  • over large areas of the body

Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

  • the condition persists or gets worse
  • you need to use this product for more than 1 week

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 product to the area 1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first

Other information

  • store at 15° to 30°C (59° to 86°F)

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

Inactive ingredients

citric acid, dibasic sodium phosphate, glycerin, purified water

Manufactured for:
QUALITEST PHARMACEUTICALS
HUNTSVILLE, AL 35811

Rev. 2/10 R6
8071710  1550

PRINCIPAL DISPLAY PANEL

This is an image of the label for Povidone Iodine 10% Solution.
POVIDONE IODINE 
povidone iodine solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0603-1550
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) POVIDONE-IODINE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
SODIUM PHOSPHATE, DIBASIC 
GLYCERIN 
WATER 
Product Characteristics
ColorBROWN (dark brown) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0603-1550-56237 mL in 1 BOTTLE, PLASTIC
2NDC:0603-1550-58473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333A04/01/1995
Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
NameAddressID/FEIBusiness Operations
Vintage Pharmaceuticals-Huntsville825839835MANUFACTURE(0603-1550)

Revised: 11/2012
 
Qualitest Pharmaceuticals

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