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Povidone Iodine Prep Swabstick

Dosage form: solution
Ingredients: POVIDONE-IODINE 1g in 100mL
Labeler: PHOENIX HEALTHCARE SOLUTIONS, LLC
NDC Code: 60913-051

Disclaimer: 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 Facts

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

POVIDONE IODINE PREP  SWABSTICK
povidone iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60913-051
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
GLYCERIN 
WATER 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:60913-051-0150 POUCH in 1 BOX
11 APPLICATOR in 1 POUCH
11 mL in 1 APPLICATOR
2NDC:60913-051-0325 POUCH in 1 BOX
23 APPLICATOR in 1 POUCH
21 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/23/2015
Labeler - PHOENIX HEALTHCARE SOLUTIONS, LLC (079146847)

Revised: 10/2017
 
PHOENIX HEALTHCARE SOLUTIONS, LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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