Label: DUAL SWAB SCRUB SWABSTICK- povidone iodine swab

  • 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 November 3, 2015

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  • Active Ingredient

    Active ingredient                Purpose

    Povidone iodine 7.5%        Antiseptic

  • Purpose

    For scrubbing procedure site, prior to antiseptic application

  • Indications and usage

    For pre-operative patient skin preparation.

  • Warnings

    ​For External Use Only

    Avoid contact with the 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 preoperative patient skin preparation:

    • scrub procedure site as required. Discard after single use and proceed to packet 2.

    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

    Lauramide DEA, Water

  • Other information

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

    Dynarex Dual Swab Povidone Iodine Scrub Swabstick

    Item #: 1209

    1209 Scrub.jpg

    Scrub Swabstick

  • INGREDIENTS AND APPEARANCE
    DUAL SWAB SCRUB SWABSTICK 
    povidone iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem 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 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-302-010.3 g in 1 POUCH; Type 0: Not a Combination Product
    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)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sion Biotext Medical Ltd532775194manufacture(67777-302)
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