POVIDONE IODINE- povidone-iodine solution 
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 10% SOLUTION

Active ingredient

Povidone-iodine, 10%

(1% available iodine)

Purpose

First aid antiseptic

Uses

first aid to help prevent infection in minor

Warnings

For external use only

Do not use

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

Stop use and ask a doctor if

Keep out of reach of children.

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

Directions

Other information

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 Type HUMAN OTC DRUG Item Code (Source) NDC:0603-1550
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) POVIDONE-IODINE 100 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color BROWN (dark brown) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0603-1550-56 237 mL in 1 BOTTLE, PLASTIC
2 NDC:0603-1550-58 473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part333A 04/01/1995
Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
Name Address ID/FEI Business Operations
Vintage Pharmaceuticals-Huntsville 825839835 MANUFACTURE(0603-1550)

Revised: 11/2012
Document Id: bda4d588-4b8d-48cc-895b-a0eee092a703
Set id: bdecbe5e-4bbb-4602-a4c7-42f52ff3461c
Version: 3
Effective Time: 20121101
 
Qualitest Pharmaceuticals