Label: POVIDONE-IODINE swab

  • NDC Code(s): 81280-003-01, 81280-003-03
  • Packager: Mazza Healthcare, LLC
  • 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 4, 2021

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  • Active ingredient

    Povidone-Iodine, USP, 10% v/v
    (equivalent to 1% titratable iodine)

  • Purpose

    Antiseptic

  • Uses

    • health care antiseptic for preparation of the skin prior to surgery
    • first aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes and burns
  • Warnings

    For external use only

    Do not use

    • in the eyes
    • on individuals who are allergic or sensitive to iodine
    • over large areas of the body
    • as first aid antiseptic longer than 1 week unless directed by doctor

    Discontinue use if irritation and redness develop.

    Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.

    Stop use and consult a doctor if the condition persists or gets worse.

    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
    • apply product on the area 1-3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.
  • Other information

    Store at room temperature 59-86ºF (15-30ºC).

  • Inactive ingredients

    citric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide

    Mazza Healthcare, LLC
    1-877-629-9242

  • Principal Display Panel - 500 Pouch Carton Label

    MH

    Mazza Healthcare

    MODEL NO.: 02-053-00

    DESCRIPTION: POVIDONE-IODINE SWABSTICKS, 4” SATURATED, NON-STERILE

    QUANTITY: 1 CASE (500 POUCHES X 3 EACH)

    LOT NO.:

    MANUFACTURE DATE:

    EXPIRY DATE:

    MANUFACTURED FOR:

    Mazza Healthcare, LLC

    Bannockburn, IL 60015 • USA

    MADE IN CHINA

    NDC 81280-003-03

    Principal Display Panel - 500 Pouch Carton Label
  • Principal Display Panel - 3 Applicators Pouch Label

    MH

    Mazza Healthcare

    Povidone-Iodine Swabsticks

    NDC 81280-003-03

    Antiseptic • Germicide • 4” Saturated

    Non-Sterile • Single Use Only

    3/pouch

    Reorder Number 02-053-00

    Principal Display Panel - 3 Applicators Pouch Label
  • Principal Display Panel - 500 Pouch Carton Label

    MH

    Mazza Healthcare

    MODEL NO.: 02-051-00

    DESCRIPTION: POVIDONE-IODINE SWABSTICKS, 4” SATURATED, NON-STERILE

    QUANTITY: 1 CASE (500 POUCHES X 1 EACH)

    LOT NO.:

    MANUFACTURE DATE:

    EXPIRY DATE:

    MANUFACTURED FOR:

    Mazza Healthcare, LLC

    Bannockburn, IL 60015 • USA

    MADE IN CHINA

    NDC 81280-003-01

    Principal Display Panel - 500 Pouch Carton Label
  • Principal Display Panel - 1 Applicator Pouch Label

    MH

    Mazza Healthcare

    Povidone-Iodine Swabstick

    NDC 81280-003-01

    Antiseptic • Germicide • 4” Saturated

    Non-Sterile • Single Use Only

    1/pouch

    Reorder Number 02-051-00

    Principal Display Panel - 1 Applicator Pouch Label
  • INGREDIENTS AND APPEARANCE
    POVIDONE-IODINE 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81280-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Povidone-Iodine (UNII: 85H0HZU99M) (Iodine - UNII:9679TC07X4) Iodine0.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Glycerin (UNII: PDC6A3C0OX)  
    Nonoxynol-10 (UNII: K7O76887AP)  
    Water (UNII: 059QF0KO0R)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81280-003-01500 in 1 CARTON03/01/2021
    11 in 1 POUCH
    12.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    2NDC:81280-003-03500 in 1 CARTON03/01/2021
    23 in 1 POUCH
    24.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C03/01/2021
    Labeler - Mazza Healthcare, LLC (830069063)
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