Label: ZEE POVIDONE IODINE (povidone iodine 10% w/w- equivalent to iodine 1% swab

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 28, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients (each swab)

    10% Povidone Iodine Solution USP, (1% available Iodine)

  • PURPOSE

    Purpose

    ​​Topical Antiseptic

  • INDICATIONS & USAGE

    Uses

    To treat minor skin cuts, and abrasions.

  • Warnings

    FOR EXTERNAL USE ONLY

  • ASK DOCTOR

    Ask a doctor before use if you have

    • deep or puncture wounds
    • serious burns
  • STOP USE

    Stop use and ask a doctor if

    • redness, irritation, swelling or pain persists or increases
    • infection occurs
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    Reverse cardboard sleeve then crush at dot between thumb and forefinger. Allow
    solution to saturate tip and apply solution to injury. 

  • STORAGE AND HANDLING

    Other Information

    Store at room temperature away from light keep from freezing or excessive heat.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water.​

  • QUESTIONS

    Questions?
    Call 1-908-362-9266 Monday through Friday, 9:00 am - 5:00 pm e.s.t.

  • Package Principal Display Panel

    10 SWABS

    (1/2 ml.)

    UNIT NO.

    U1-16A

    POVIDONE - IODINE SWABS U.S.P

    (ANTISEPTIC)

    CONTAINS: POVIDONE IODINE 10%

    EQUIVALENT TO 1% AVAILABLE IODINE

    ZEE®

    Distributed by: ZEE Medical Distributors, LLC

    Mason, OH 45040

    Box

  • INGREDIENTS AND APPEARANCE
    ZEE POVIDONE IODINE 
    povidone iodine 10% w/w (equivalent to iodine 1%) swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42961-023
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42961-023-0110 in 1 BOX05/12/2022
    10.5 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00305/12/2022
    Labeler - Cintas Corporation (056481716)
    Establishment
    NameAddressID/FEIBusiness Operations
    James Alexander Corporation040756421manufacture(42961-023)
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