Label: PREP SOLUTION TOPICAL ANTISEPTIC MICROBICIDE- povidone-iodine solution

  • NDC Code(s): 67326-350-04, 67326-350-05, 67326-350-06, 67326-350-07, view more
    67326-350-08, 67326-350-09, 67326-350-10
  • Packager: Degasa SA De CV
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 5, 2023

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  • Drug Facts

  • Active Ingredient

    Povidone- Iodine, 10% (equivalent to 1% available Iodine).

    Purpose

    Antiseptic

  • Inactive ingredients

    Citric Acid, Disodium Phosphate, Glycerin, Purified Water, Sodium Citrate, Tween 80.

  • Uses

    Healthcare antiseptic for preparation of the skin prior to surgery. First aid antiseptic to help prevent infection in minor cuts, scrapes and burns.

  • Warnings:

    For external use only

    Do not use:

    In the eyes, on deep or puncture wounds, on individuals who are allergic or sensitive to iodine, as a first aid antiseptic longer than one week and in serious burns.

    Stop use and ask a doctor if

    Irritation and redness develop and if conditions persist 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

    For preparation of the skin prior to surgery:

    Skin preparation for the skin: 1.Clean the area, 2. Apply product to the operative site prior to surgery.

    For first aid antiseptic

    1. Clean the affected area, 2. Apply a small amount of the product on the area 1-3 times daily, 3. May be covered with a sterile bandage, 4. If bandaged, let dry first. 

  • Other information

    Store at room temperature 20-25° C (68-77°F). Not made with natural rubber latex.

  • Questions?

    Call: 800-925-4733

  • Principal Display Panel

    Label - PrepSolution 32oz

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    PREP SOLUTION   TOPICAL ANTISEPTIC MICROBICIDE
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67326-350
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67326-350-0559 mL in 1 BOTTLE; Type 0: Not a Combination Product03/14/2011
    2NDC:67326-350-06118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2007
    3NDC:67326-350-07237 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2007
    4NDC:67326-350-08474 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2007
    5NDC:67326-350-04948 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2007
    6NDC:67326-350-093785 mL in 1 JUG; Type 0: Not a Combination Product01/01/2007
    7NDC:67326-350-1089 mL in 1 BOTTLE; Type 0: Not a Combination Product11/17/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)01/01/2007
    Labeler - Degasa SA De CV (812771980)
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