Label: IODINE- povidone-iodine solution

  • NDC Code(s): 65734-317-00, 65734-317-72
  • Packager: Swabplus Inc.
  • 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

If you are a consumer or patient please visit this version.

  • Drug Facts Active ingredient

    Povidone Iodine 10%, equal to 1% available Iodine

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  • Purpose

    Antiseptic

    Uses

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

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  • Keep out of reach of children

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

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  • 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.
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  • 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

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  • 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.

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  • Inactive ingredients

    Glycerin, water

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  • 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.

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  • Package and Labeling

    Image of iodine carton  

    image of iodine carton

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  • INGREDIENTS AND APPEARANCE
    IODINE 
    povidone-iodine solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:65734-317
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Povidone-Iodine (UNII: 85H0HZU99M) (Iodine - UNII:9679TC07X4) Iodine 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Product Characteristics
    Color brown (dark) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65734-317-72 72 in 1 PACKAGE
    1 NDC:65734-317-00 0.15 mL in 1 APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 03/01/2003
    Labeler - Swabplus Inc. (876441549)
    Registrant - Swabplus Inc. (876441549)
    Establishment
    Name Address ID/FEI Business Operations
    Swabplus Inc. 876441549 manufacture(65734-317) , relabel(65734-317) , repack(65734-317)
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