GOOD CARE POVIDONE IODINE- povidone-iodine swab

Good Care Povidone Iodine by

Drug Labeling and Warnings

Good Care Povidone Iodine by is a Otc medication manufactured, distributed, or labeled by Dalian Goodwood Medical Care Ltd., Dalian Goodwood Medical Care Ltd. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Povidone Iodine USP, 10% w/v

(equivalent to 1% titratable iodine)

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

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

Warnings

For external use only.

DO NOT USE

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.

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

For preparation of the skin prior to surgery clean the affected area, remove swab by the 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.

STORAGE AND HANDLING

Other information

Store at room temperature: 15 degrees - 30 degrees C (59 degrees - 86 degrees F)

INACTIVE INGREDIENT

Inactive ingredients

citric acid, glycerin, nonoxynol-8, purified water, sodium hydroxide

SPL UNCLASSIFIED SECTION

Manufactured by DALIAN GOODWOOD MEDICAL CARE LTD.

3-91 Jiulicun Yongzheng Street Jinzhou District Dalian China 116100

Tel: +86-411-87857288

Made in China  www.dl-goodwood.com

PRINCIPAL DISPLAY PANEL

Good Care
Povidone Iodine, USP Swabsticks
Antiseptic    Germicide

• Topical pre-surgical and first aid antiseptic swabstick
• For hospital and professional use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GOOD CARE POVIDONE IODINE 
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50685-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50685-001-01	2 mL in 1 POUCH; Type 0: Not a Combination Product	10/01/2010
2	NDC: 50685-001-03	5.5 mL in 1 POUCH; Type 0: Not a Combination Product	10/01/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/01/2010

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(50685-001)