Label: IODINE- povidone-iodine solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 February 16, 2015

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  • Drug Facts Active 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 in 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 occurs.

    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 continues or increases. infection occurs

  • Administration

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

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

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

  • Inactive ingredients

    Glycerin, water

  • Manufacturer Statements

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

    The COLOR RING is copyrighted by Swabplus Inc.©2007 SWABPLUS INC.

  • Package and Labeling

    Image of iodine carton  

    image of iodine carton

  • INGREDIENTS AND APPEARANCE
    IODINE 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65734-317
    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
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Product Characteristics
    Colorbrown (dark) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65734-317-7272 in 1 PACKAGE
    1NDC:65734-317-000.15 mL in 1 APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C03/01/2003
    Labeler - Swabplus Inc. (876441549)
    Registrant - Swabplus Inc. (876441549)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swabplus Inc.876441549manufacture(65734-317) , relabel(65734-317) , repack(65734-317)
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