Label: DYNAREX POVIDONE IODINE SURGICAL SCRUB- povidone iodine surgical scrub solution liquid

  • NDC Code(s): 67777-142-50, 67777-142-51, 67777-142-60, 67777-142-61
  • Packager: Dynarex Corporation
  • 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 December 1, 2022

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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
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    MONOETHANOLAMINE (UNII: 5KV86114PT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-142-5124 in 1 CASE05/08/2018
    1NDC:67777-142-50473 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:67777-142-614 in 1 CASE05/08/2018
    2NDC:67777-142-603790 mL in 1 BOTTLE; Type 0: Not a Combination Product
    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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