Label: FIRST AID DIRECT POVIDONE IODINE- povidone iodine antiseptic swab

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

Drug Label Information

Updated December 28, 2023

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  • Active Ingredients (each swab)

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

  • Purpose

    Topical Antiseptic

  • Uses

    To treat minor skin cuts, and abrasions

  • WARNINGS

    FOR EXTERNAL USE ONLY

  • Ask a doctor before use if you have

    • deep or puncture wounds
    • serious burn
  • Stop use and ask doctor if

    • redness, irritation, swelling or pain persists or increases
    • infection occurs
  • Keep out of reach of children. 

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

  • Directions:

    Reverse cardboard sleeve then crush at dot between thumb and forefinger.

    Allow solution to saturate tip and apply solution to injury.

  • Other Information

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

  • Inactive Ingredients

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

  • Questions?

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

  • Package Label Principal Display Panel - Box of 10 Swabs

    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

    DISTRIBUTED BY

    first aid direct

    Mason, OH 45040

    carton

  • INGREDIENTS AND APPEARANCE
    FIRST AID DIRECT POVIDONE IODINE 
    povidone iodine antiseptic swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42961-110
    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 (UNII: GR686LBA74)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    SODIUM HYDRIDE (UNII: 23J3BHR95O)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42961-110-0210 in 1 BOX05/16/2022
    110 mg in 1 AMPULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00305/16/2022
    Labeler - CINTAS CORPORATION (056481716)
    Establishment
    NameAddressID/FEIBusiness Operations
    JAMES ALEXANDER CORP040756421manufacture(42961-110)
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