PDI Duo-Swab Povidone-Iodine Antiseptic Prep and Scrub Swabsticks Ones

Dosage form: stick
Ingredients: Povidone-Iodine 10mg in 1mL
Labeler: Professional Disposables International, Inc.
NDC Code: 10819-3890

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% titratable iodine)

Purpose

Antiseptic

Uses
  • Healthcare 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
  • 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 persists for more than 72 hours or gets worse, consult a doctor.

Consult a doctor in case of
  • deep or puncture wounds
  • animal bites
  • serious burns.

Stop use and ask 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 treatment area
  • remove swab by stick
  • apply to the operative site prior to surgery
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
  • may be covered with a sterile bandage
  • if bandaged, let dry first

Other information

Store at room temperature. Avoid excessive heat.

Inactive ingredients

Purified Water, Sodium Hydroxide

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

Principal Display Panel

PDI(R)

Duo-Swab Povidone-Iodine Swabstick

Cleansing Scrub Swabstic (1's) and
Antiseptic Prep Swabstick (1's)

For Professional and Hospital Use

Step 1 (Scrub)
Step 2 (Prep)

25 Sets [1 Prep and 1 Scrub Swabstick per set]

Packet Swabstick (1's)

Box Swabstick (1's)

PDI DUO-SWAB POVIDONE-IODINE  ANTISEPTIC PREP AND SCRUB SWABSTICKS ONES
povidone iodine stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10819-3890
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:10819-3890-15 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(10819-3890)

Revised: 11/2011
 
Professional Disposables International, Inc.

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.

Hide
(web5)