POVIDONE IODINE PREP SWABSTICK- povidone iodine solution

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredient

Povidone Iodine USP 10% v/v

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 in the eyes
• use on individuals who are allergic or sensitive to iodine
• apply over large areas of the body
• use 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 Center right away.

Directions:

For preparation of the skin prior to surgery

• clean the affected area
• apply a small amount of this product on the area

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: 59o - 86oF (15o - 30oC)

Inactive ingredients:

citric acid, glycerin, Makon 8, purified water, sodium hydroxide

Principal Display Panel

NDC: 60913-051-01

Phoenix Healthcare Solutions LLC

"An Innovative Medical Manufacturer"

Povidone Iodine Swabsticks

10% Povidone Iodine, USP

For Professional and Hospital Use

Antispetic/ Germicide

50 Pouches Per Box

1 Swabstick Per Pouch

NDC: 60913-051-03

Phoenix Healthcare Solutions LLC

"An Innovative Medical Manufacturer"

Povidone Iodine Swabsticks

10% Povidone Iodine, USP

For Professional and Hospital Use

Antispetic/ Germicide

25  Pouches Per Box

3  Swabsticks Per Pouch

INGREDIENTS AND APPEARANCE

POVIDONE IODINE PREP  SWABSTICK
povidone iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60913-051
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	1 g  in 100 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: 60913-051-01	50 in 1 BOX	06/23/2015
1		1 in 1 POUCH
1		1 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC: 60913-051-03	25 in 1 BOX	06/23/2015
2		3 in 1 POUCH
2		1 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/23/2015

Labeler - PHOENIX HEALTHCARE SOLUTIONS, LLC (079146847)