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GOOD CARE POVIDONE IODINE SWABSTICKS (povidone-iodine) swab
[Dalian Goodwood Medical Care Ltd.]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1ae21018-c7cc-4e9a-82e2-2a3f5a136195

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph 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

Good Care Povidone Iodine, USP Swabsticks

Active Ingredient

Povidone Iodine USP, 10%

Purpose

Antiseptic

Uses

Health-care antiseptic for preparation of the skin prior to surgery
First aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes, and burns

Warnings

For external use only. Do not use or apply in the eyes
on individuals who are allergic or sensitive to iodine
over large areas of the body
as a first aid antiseptic longer than 1 week unless directed by a doctor

Discontinue use if irritation and redness develop.

Consult a doctor in case of deep or puncture wounds, animal bites, serious burns.

Stop use and consult a doctor if the condition persists or gets worse.

Keep out of reach of children.

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

Directions

For preparation of the skin prior to surgery clean the affected area, remove swab by stick, apply to the operative site prior to surgery

For use as a first aid antiseptic clean the affected area, apply a small amount of this product on 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 degrees - 30 degrees C (59 degrees - 86 degrees F)

Inactive Ingredients

Purified water, Povidone Iodine, Citric Acid Disodium Hydrogen Phosphate Dodecahydrate Potassium Iodate Nonoxynol

Manufactured by Dalian Goodwood Medical Care Ltd.

Made in China

Good Care Povidone Iodine, USP Swabsticks (1s) (50 pouches/box) (50685-009-01)

PovidoneIodine1s

PovidoneIodine1s50pouchesbox

Good Care Povidone Iodine, USP Swabsticks (2s) (25 pouches/box) (50685-009-02)

PovidoneIodine2s

PovidoneIodine2s25pouchesbox

Good Care Povidone Iodine, USP Swabsticks (3s) (25 pouches/box) (50685-009-03)

PovidoneIodine3s

PovidoneIodine3s25pouchesbox

GOOD CARE POVIDONE IODINE SWABSTICKS
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50685-009
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (IODINE)	IODINE	10 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER
CITRIC ACID MONOHYDRATE
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE
POTASSIUM IODATE

Packaging
#	Item Code	Package Description
1	NDC:50685-009-01	50 in 1 BOX
1		0.7 g in 1 PACKET
2	NDC:50685-009-02	25 in 1 BOX
2		1.4 g in 1 PACKET
3	NDC:50685-009-03	25 in 1 BOX
3		2.1 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333E	02/13/2013

Labeler - Dalian Goodwood Medical Care Ltd. (529575699)

Registrant - Dalian Goodwood Medical Care Ltd. (529575699)

Establishment
Name	Address	ID/FEI	Business Operations
Dalian Goodwood Medical Care Ltd.		529575699	manufacture(50685-009)

Revised: 02/2013

Document Id: acfdbb6e-316a-4fa0-9819-7612d49eb92b

Set id: 1ae21018-c7cc-4e9a-82e2-2a3f5a136195

Version: 1

Effective Time: 20130227

Dalian Goodwood Medical Care Ltd.

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