ISODINE COPITOS (POVIDONE-IODINE ) SOLUTION [SWABPLUS INC.]

ISODINE COPITOS (POVIDONE-IODINE ) SOLUTION [SWABPLUS INC.]
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NDC 65734-511-00, 65734-511-72
Set ID 8629d5dd-2a59-4184-89e5-d63b77e66226
Category HUMAN OTC DRUG LABEL
Packager Swabplus Inc.
Generic Name
Product Class
Product Number
Application Number PART333C
  • Drug FactsActive ingredient

    Povidone iodine 10%, equal to 1% available Iodine

  • Purpose

    Antiseptic

    Uses First aid to help prevent infection due to minor cuts, scrapes and burns.

  • Keep out of reach of children

    if swallowed, get medical help of contact a Poison Control Center right away.

  • Directions

    • Hold the swab vertically, with the color ring tip upwards, Hold n the center of the tube with one hand at the color ring with the other.
    • Gently snap the tip with the color ring, Formula inside the tube flows down and fills the opposite tip.
    • Apply the product to the affected area.
    • Discard swab after use.
  • Warnings

    For external use only. Keep out of eyes and ear canal. Non-Sterile. Discontinue use if irritation.

    Do not use. If you are sensitive to Iodine. Longer than one week unless directed by a doctor.

    Stop use and ask a doctor. If you have deep or puncture wounds, or serious burns. redness, irritation, swelling or pain continue or increas., infedtion occurs.

  • Administration

    For adults and children 2 and older: for minor wounds, burns and infections, apply directly to affected area. May be covered with a bandage.

    Children under 2 years of age: Do not use, consult a doctor.

    Other information: Store art room temperature, Avoid direct sunlight, excessive heat and moisture.

  • Inactive ingredients

    Glycerin, water

  • Manufacturer Statement

    Patented and manufactured by Swabplus Inc. Rancho Cucamonga, CA 91730 USA Made in USA

    Imported and Distributed by Boehringer Ingelheim

  • Package and Labeling

    Image of iodine carton label

    Image of iodine carton label

  • INGREDIENTS AND APPEARANCE
    ISODINE COPITOS  
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65734-511
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Povidone-Iodine (UNII: 85H0HZU99M) (Iodine - UNII:9679TC07X4) Iodine10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorbrown (dark) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65734-511-7272 in 1 PACKAGE
    1NDC:65734-511-000.15 mL in 1 APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C06/01/2008
    Labeler - Swabplus Inc. (876441549)
    Registrant - Swabplus Inc. (876441549)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swabplus Inc.876441549manufacture(65734-511) , relabel(65734-511) , repack(65734-511)

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