Label: DUAL SWAB SCRUB SWABSTICK- povidone iodine swab

  • Category: HUMAN OTC DRUG LABEL

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 4, 2015

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  • Active Ingredient

    Active ingredient                Purpose

    Povidone iodine 10%        Antiseptic

  • Purpose

    For antiseptic application at  procedure site.

  • 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:

    • Apply to procedure siteand 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

    Anhydrous citric acid, disodium hydrogen phosphate, Water

  • Other information

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

    Dynarex Dual Swab Povidone Iodine Prep Swabstick

    Item #: 1210

    1210 Prep.jpg

    Prep Swabstick

  • INGREDIENTS AND APPEARANCE
    DUAL SWAB SCRUB SWABSTICK 
    povidone iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-303
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM PHOSPHATE, DIBASIC ANHYDROUS (UNII: 22ADO53M6F)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-303-010.3 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(67777-303)
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