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North PVP Iodine Wipe

Dosage form: swab
Ingredients: POVIDONE-IODINE 10mg in 1mL
Labeler: North Safety Products
NDC Code: 0498-0120

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

PVP Iodine Wipes

Active ingredient

Povidone-iodine 10%

(equivalent to 1% titratable iodine)

Purpose

First aid antiseptic

Uses
  • first aid antiseptic to help prevent infection in minor cuts, scrapes and burns

Warnings

For external use only.

Ask a doctor before use if you have
  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if
  • condition worsens or persists for more than 72 hours
  • irritation and redness develops

Keep out of reach of children.

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

Directions
  • clean the affected area
  • apply1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first

Other information
  • do not use on individuals who are allergic or sensitive to iodine
  • store at controlled temperature 59-86ºF (15-30ºC)
  • do not use if pouch is open or torn
  • discard after each use

Inactive ingredients

nonoxynol 9, water

Questions

800-430-5490

Principal Display Panel

PVPWipe.jpg

North PVP Iodine Wipe

NORTH PVP IODINE WIPE 
povidone-iodine 10% swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-0120
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
NONOXYNOL-9 
WATER 
Packaging
#Item CodePackage Description
1NDC:0498-0120-3410 POUCH in 1 CARTON
10.3 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/07/2017
Labeler - North Safety Products (019777263)
Registrant - North Safety Products (019777263)
Establishment
NameAddressID/FEIOperations
North Safety Products019777263pack(0498-0120)
Establishment
NameAddressID/FEIOperations
Sion Biotext Medical532775194manufacture(0498-0120)

Revised: 12/2017
 
North Safety Products

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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