RxNorm Names

Review RxNorm Normal Forms

POVIDONE IODINE solution
[Qualitest Pharmaceuticals]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=bdecbe5e-4bbb-4602-a4c7-42f52ff3461c

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

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

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 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 (IODINE)	POVIDONE-IODINE	100 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID
SODIUM PHOSPHATE, DIBASIC
GLYCERIN
WATER

Product Characteristics
Color	BROWN (dark brown)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description
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

Daily Med

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