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PVP-I Prep Pads foil-foil

Dosage form: swab
Ingredients: Povidone-iodine 0.9g in 100mL
Labeler: Dukal Corporation
NDC Code: 65517-0031

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%

Purpose:

Antiseptic

Use:

For preparation prior to surgery. Helps to reduce bacteria that can potentially cause skin infection.

Warnings:

For external use only.

Do not apply to persons allergic to iodine. Do not use in the eyes.

  • Ask a doctor before use if injuries are deep wounds, puncture wounds, serious burns.

  • Stop use and ask a doctor if irritation and redness develop, condition persists for more than 72 hours, infection occurs.
  • Avoid pooling beneath the patient. Prolonged exposure to wet solution may cause skin irritation.

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

Directions:

Clean the area. Apply product to the operative site prior to surgery using pad to prep desired area.

Other Information:

1% titratable iodine, for hospital or professional use only. Store at ambient temperatures.

Inactive Ingredients:

Citric Acid, Glycerin, Sodium Hydroxide, Potassium Iodide, Alkyl Glucoside, Nonoxynol-10, Hydroxyethyl Cellulose and Purified Water.

Principal Display Panel - PVP-I Prep Pads Foil 865-8000 Case Label

DUKAL™
CORPORATION

REF 865-8000

NON-STERILE POVIDONE-IODINE 10%

POVIDONE-IODINE
PREP PADS

8000/Case

1/Pack

Manufactured For: DUKAL CORPORATION • (631) 656-3800

Ronkonkoma, NY 11779 • www.dukal.com

Made in China, Hecho en China, Fabriqué en Chine

(01) 40665973024903

Principal Display Panel - PVP-I Prep Pads Foil 865-8000 Pouch Label

DUKAL™
CORPORATION

REF 865

NON-STERILE
POVIDONE-IODINE 10%

Povidone-Iodine
Prep Pad

1
/Pouch

Manufactured For:

DUKAL CORPORATION • (631) 656-3800

Ronkonkoma, NY 11779 • www.dukal.com

Made in China

PVP-I PREP PADS FOIL-FOIL 
povidone-iodine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65517-0031
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Povidone-iodine (Iodine) Iodine0.9 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Glycerin 
Hydroxyethyl Cellulose (2000 MPA.S At 1%) 
Nonoxynol-10 
Citric Acid Monohydrate 
Sodium hydroxide 
Water 
C12-20 Alkyl Glucoside 
Potassium iodide 
Packaging
#Item CodePackage Description
1NDC:65517-0031-18000 POUCH in 1 CASE
1100 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/31/2018
Labeler - Dukal Corporation (791014871)
Establishment
NameAddressID/FEIOperations
Changzhou Maokang Medical Products Co.,Ltd421317073MANUFACTURE(65517-0031)

Revised: 01/2018
 
Dukal Corporation

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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