POVIDONE IODINE PREP- povidone iodine swab

Povidone Iodine Prep by

Drug Labeling and Warnings

Povidone Iodine Prep by is a Otc medication manufactured, distributed, or labeled by PHOENIX HEALTHCARE SOLUTIONS, LLC. Drug facts, warnings, and ingredients follow.

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

Phoenix Healthcare Solutions LLC

An Innovative Medical Manufacturer

NDC: 60913-999-02

200 Individual Pads

Povidone Iodine Prep Pads

Medium

For Individual, Professional and Hospital Use

Saturated with 10% Povidone Iodine for external use only

Latex Free

PIN DOT WOVEN

INGREDIENTS AND APPEARANCE

POVIDONE IODINE PREP  
povidone iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60913-999
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: 60913-999-02	200 in 1 CARTON	02/26/2015
1		1 mL in 1 PACKET; 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	02/26/2015

Labeler - PHOENIX HEALTHCARE SOLUTIONS, LLC (079146847)