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PVP Iodine Prep Pad Medium and Large

Medically reviewed on November 28, 2017

Dosage form: swab
Ingredients: POVIDONE-IODINE 10mg in 1mL
Labeler: Professional Disposables International, Inc.
NDC Code: 10819-3883

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% w/w (equivalent to 1.0% titratable iodine)

Purpose

Antiseptic

Uses
  • A broad spectrum antiseptic for topical application for preparation of the skin prior to surgery.
  • First Aid antiseptic to help prevent the risk of skin infection in minor cut, scrapes and burns.

Warnings

For external use only

Do not use

  • in the eyes, nose or mouth
  • on individuals who are allergic or sensitive to iodine
  • over large areas of the body
  • as a first aid antiseptic longer than one week unless directed by a doctor

Discontinue use if irritation and redness develop. If condition persist for more than 72 hours or gets worse, consult a healthcare provider

Consult a healthcare provier in case of

  • Deep or puncture wounds
  • animal bites
  • serious burns
  • if you are pregnant

Avoid pooling

Keep out of reach of children.

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

Directions

For the preparation of the skin prior to surgery

  • clean the treatment area
  • remove applicator
  • apply to the operative site prior to surgery
  • allow to dry

For use as a first aid antiseptic

  • clean the treatment area
  • apply a small amount of this product on the treatment area 1-3 times daily as directed
  • may be covered with a sterile bandage
  • if bandaged, let dry before applying bandage to prevent possible irritation

Other information
  • Store at room temperature
  • Avoid excessive heat

Inactive ingredients

Purified Water, Sodium Hydroxide

Questions?

Professional Disposables International, Inc.
Orangeburg, NY 10962-1376
USA - 1-800-999-6423
www.pdipdi.com         Made in USA

Principal Display Panel and Labels

Packet 1 swabstick

Box 1 swabstick

Packet 3 swabsticks

Box 3 swabsticks

Packet med

Box med

Packet large

Box large

PVP IODINE PREP PAD  MEDIUM AND LARGE
providone iodine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10819-3883
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:10819-3883-1100 PACKET in 1 BOX
10.80 mL in 1 PACKET
2NDC:10819-3883-3100 PACKET in 1 BOX
22.20 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/1978
PVP IODINE PREP SWABSTICK  ONES AND THREES
providone iodine stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10819-3885
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:10819-3885-150 PACKET in 1 BOX
12.50 mL in 1 PACKET
2NDC:10819-3885-225 PACKET in 1 BOX
27.00 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/1978
Labeler - Professional Disposables International, Inc. (800777117)
Establishment
NameAddressID/FEIOperations
Professional Disposables International, Inc.800777117MANUFACTURE(10819-3885)

 
Professional Disposables International, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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