Label: ANTISEPTIC PATIENT PREOPERATIVE SKIN PREPARATION AND SURGICAL HAND SCRUB- povidone-iodine solution

  • NDC Code(s): 67326-352-03, 67326-352-05, 67326-352-06, 67326-352-07, view more
    67326-352-08
  • Packager: Degasa SA De CV
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 5, 2023

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  • Active Ingredient

    Povidone Iodine 7.5%

  • Purpose

    Antiseptic

  • Uses

    Patient preoperative skin preparation:

    Surgical hand scrub:

    • For preparation of the skin prior to surgery
    • Helps reduce bacteria that potentially can cause skin infection
    • Significantyl reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care
  • WARNINGS: For External Use Only

    Do not use

    Stop use and ask a doctor if

    • In the eyes
    • Heat prior to application
    • On individuals who are allergic or sensitive to Iodine
    • Irritation and redness develop
    • If condition persists for more than 72 hous consult a doctor

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    Patient preoperative skin preparation:

    Surgical hand scrub:

    • Clean the area
    • Apply product to the operative site prior to surgery
    • Scrub thoroughly for 5 minutes
    • Rinse off with a sterile gauze saturated with water
    • Clean under nails with a nail pick. Nail should be maintained with a 1 millimeter free edge
    • Wet hands and forearms
    • Apply 5 millileters (teaspoonful) or palmfull to hands and forearms
    • Scub thoroughly for 5 minutes with a sterile brush
    • Paying particular attention to the nails, cuticles, and interdigital spaces
    • Rinse and repeat scrub
  • Other information

    Store at room temperature 20-25°C (68-77°F)

  • Inactive Ingredients

    Disodium Phosphate, Glycerin, Hidroxyethylcellulose, Monoethanolamine, Dionized Water

  • Package Labeling

    1

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC PATIENT PREOPERATIVE SKIN PREPARATION AND SURGICAL HAND SCRUB 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67326-352
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MONOETHANOLAMINE (UNII: 5KV86114PT)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67326-352-0748 in 1 CASE08/13/2015
    159 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:67326-352-0848 in 1 CASE08/13/2015
    2118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:67326-352-0624 in 1 CASE08/13/2015
    3237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:67326-352-0324 in 1 CASE08/13/2015
    4474 mL in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:67326-352-0512 in 1 CASE08/13/2015
    5948 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)08/13/2015
    Labeler - Degasa SA De CV (812771980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Degasa, S.A. de C.V.812771980manufacture(67326-352)
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