Label: SWABSTICKS TRIPLE PACK- povidone-iodine swab

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 19, 2015

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  • Active ingredient

    Povidone-Iodine solution 10.0% v/v

  • Purpose

    Antiseptic

  • Uses

    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
    •
    Longer than one week unless directed by a doctor
    •
    On individuals who are allergic or sensitive to iodine
    •
    Or apply over large areas of the body

    Stop use and ask a doctor if

    •
    irritation and redness develop
    •
    symptoms last for more than 72 hours
    •
    in case of deep puncture wounds, animal bites or serious burns, consult a doctor

    Keep out of reach of children.

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

  • Directions

    •
    Clean the affected area
    •
    For preparation of the skin prior to surgery: apply product to the operative site prior to surgery
    •
    For first aid antiseptic: apply a small amount of this product on the area one to three times daily. May be covered with a sterile bandage. If bandaged, let dry first
  • Other information

    •
    Protect from freezing
    •
    Avoid excessive heat
  • Inactive ingredients

    Citric Acid, Disodium Phosphate, Glycerine, Nonoxinol, Purified Water, Sodium Hydroxide

  • Questions?

    www.medline.com

    Manufactured for Medline Industires, Inc.,

    Mundelein, IL 60060 USA. Made in China

    To Order Call: 1-800-MEDLINE RK14LPD

  • Package Label - Box Principal Display Panel top

    Povidone Iodine Antiseptice - Swabsticks Triple Pack - Principal Display Panel Top

    NDC 53329-942-02

    Medline

    Swabsticks

    REF 58482

    Swabsticks Triple Pack

    Povidone Iodine Antiseptic

    Non-Sterile

    •
    For Professional and Hospital Use
    •
    For External Use Only
    •
    Discard after single use

    QTY 3

  • INGREDIENTS AND APPEARANCE
    SWABSTICKS TRIPLE PACK 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-942
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-942-023 in 1 POUCH
    110 mg in 1 APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/26/2014
    Labeler - Medline Industries, Inc. (025460908)
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