DUAL SWAB SCRUB SWABSTICK (POVIDONE IODINE) SWAB [DYNAREX CORPORATION]

DUAL SWAB SCRUB SWABSTICK (POVIDONE IODINE) SWAB [DYNAREX CORPORATION]
PDF | XML

NDC 67777-303-01
Set ID 8092e6e8-467a-4260-977f-96c509c64832
Category HUMAN OTC DRUG LABEL
Packager Dynarex Corporation
Generic Name
Product Class
Product Number
Application Number PART333C
  • 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)

Related Drugs