DYNAREX POVIDONE IODINE SURGICAL SCRUB (POVIDONE IODINE SURGICAL SCRUB SOLUTION) LIQUID [DYNAREX CORPORATION]

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DYNAREX POVIDONE IODINE SURGICAL SCRUB (POVIDONE IODINE SURGICAL SCRUB SOLUTION) LIQUID [DYNAREX CORPORATION]
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NDC 67777-142-50, 67777-142-60
Set ID 6f053e55-cbf6-9072-e053-2991aa0a2edd
Category HUMAN OTC DRUG LABEL
Packager Dynarex Corporation
Generic Name
Product Class
Product Number
Application Number PART333E
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  • Active Ingredient

    Povidone-iodine 7.5%

  • Purpose

    Healthcare Antiseptic

  • Uses

    • Surgical hand scrub which significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care.
    • Preoperative skin preparation for the preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection
  • Warnings

    For external use only

    Do Not Use

    • if allergic to iodine
    • in the eyes

    Stop use and ask a doctor if

    • irritation and redness develop
    • condition persists for more than 72 hours

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Surgical hand scrub: Clean under nails with a nail pick. Nails should be maintained with a 1 millimeter free edge. Wet hands and forearms. Apply 5 milliliters (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for five minutes paying particular attention to the nails, cuticles, and interdigital spaces. Rinse and repeat scrub.
    • Preoperative skin preparation: Clean the area. Apply product to the operative site prior to surgery.
  • Other

    Store at controlled room temperature.

  • Inactive Ingredients

    Citric Acid, Disodium Phosphate, Glycerin, Puried Water, Sodium Citrate, Tween 80

  • Questions?

    1-888-DYNAREX

  • Labeling

    1425

  • INGREDIENTS AND APPEARANCE
    DYNAREX POVIDONE IODINE SURGICAL SCRUB 
    povidone iodine surgical scrub solution liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-142
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE100 mg  in 7.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    MONOETHANOLAMINE (UNII: 5KV86114PT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-142-50473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/08/2018
    2NDC:67777-142-603790 mL in 1 BOTTLE; Type 0: Not a Combination Product05/08/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/08/2018
    Labeler - Dynarex Corporation (008124539)
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