Label: DUAL SWAB POVIDONE-IODINE PREP- povidone iodine kit

  • NDC Code(s): 67777-302-01, 67777-303-01, 67777-414-01
  • Packager: Dynarex Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated January 24, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient                                          Purpose

    Povidone Iodine Scrub 7.5% w/w                Antiseptic

    Povidone Iodine Prep 10% w/w                  Antiseptic

  • Purpose

    Uses

    Povidone Iodine Scrub Swabstick - For scrubbing procedure site, prior to antiseptic application.

    Povidone Iodine Prep Swabstick - For antiseptic application at procedure site.

  • SPL UNCLASSIFIED SECTION

  • INDICATIONS & USAGE

    Indications and Usage

    • For pre-operative patient skin preparation.
  • Warnings

    ​For External Use Only

    Avoid contact with eyes. If contact occurs, flush with water.

  • Stop Use

    Stop use and ask a healthcare professional if;

    • condition worsens or persists for more than 72 hours
    • if pain, irritation, redness or swelling occurs
  • Ask a Doctor

    Ask a doctor before use if you have:

    • deep puncture wounds
    • animal bites
    • serious wounds
  • DO NOT USE

    Do Not Use:

    • as a first aid antiseptic for more than 1 week
    • over large areas of the body
  • KEEP OUT OF REACH OF CHILDREN

    Keep Out Of Reach Of Children

    • if swallowed, get medical help or contact a Poison Control Center immediately .​
  • Dosage and Administration

    Directions

    ​For pre-operative patient skin preparation:

    • ​Apply to procedure site and allow to dry.
    • discard after single use.
    • If not ready for immediate venipuncture, cover the area with a dry sterile gauze.

    As a first aid antiseptic:

    • ​clean affected area
    • apply to wound once or twice daily
    • may be covered with a sterile bandage
    • if bandaged let dry first

    Tear at notch, remove applicator, use only once.

  • Inactive Ingredients

    • Povidone Iodine 7.5% Scrub Solution - Lauramide DEA, water
    • Povidone Iodine 10% Prep Solution - Anhydrous citric acid, disodium hydrogen phosphate, water
  • Other information

    • Store at room temperature
    • Avoid excessive heat
  • Principal Display panel

    Dynarex Dual Swab Prep and Scrub Kit

    Item 1207

    1207_pouches.jpg

    Pouches

  • INGREDIENTS AND APPEARANCE
    DUAL SWAB POVIDONE-IODINE PREP 
    povidone iodine kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-414
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-414-011 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package04/05/2017
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 125 POUCH 32.5 mL
    Part 225 POUCH 32.5 mL
    Part 1 of 2
    DUAL SWAB POVIDONE-IODINE PREP 
    povidone iodine swab
    Product Information
    Item Code (Source)NDC:67777-302
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE7.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-302-011.3 mL in 1 POUCH; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C
    Part 2 of 2
    DUAL SWAB POVIDONE-IODINE PREP 
    povidone iodine swab
    Product Information
    Item Code (Source)NDC:67777-303
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM PHOSPHATE, DIBASIC DODECAHYDRATE (UNII: E1W4N241FO)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-303-011.3 mL in 1 POUCH; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C11/15/2015
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)