Label: SANIISWAB AI- ethyl alcohol, povidone iodine swab

  • NDC Code(s): 84456-493-01, 84456-493-02
  • Packager: POLLEY MED LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 8, 2024

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  • ACTIVE INGREDIENT

    Alcohol 62%. Purpose: Antiseptic

    Povidone Iodine 10%. Purpose: Antiseptic

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

    Two-step method to clean and sanitize the skin of the inner nostrils

    • Cleans with alcohol
    • Sanitizes with povidone iodine
  • WARNINGS

    Flammable, keep away from fire and flames

    For external use only

  • DO NOT USE

    Do Not Use:

    • In eyes or mouth
    • If product is opened or damaged
    • If you are allergic to iodine or to any ingredients

    Stop use and ask a doctor if redness, pain, or irritation appear and lasts more than 72 hours. Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    For adults and children 12 years of age and older only

    To be administered by medical personnel

    Step 1. Cleaning. Open Step 1 packet and hold handle, inserting one swab tip into each nostril. Swab lower interior lining inside the nose in a circular motion for 30 seconds. Handle guard protects against insertion of swab tip beyond the nostrils. Discard.

    Step 2. Sanitizing. Repeat Step 1 with Step 2 packet. Discard.

  • STORAGE AND HANDLING

    • Protect from excessive moisture
    • Avoid freezing and excessive heat above 40 °C (104 °F)
    • Store at room temperature 20-25 °C (68-77 °F)
  • INACTIVE INGREDIENT

    Water.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PRINCIPAL DISPLAY PANEL

    Package Label

  • INGREDIENTS AND APPEARANCE
    SANIISWAB  AI
    ethyl alcohol, povidone iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84456-493
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE0.1 g  in 1 g
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84456-493-02100 in 1 BOX10/17/2024
    1NDC:84456-493-010.25 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)10/17/2024
    Labeler - POLLEY MED LLC (125097794)
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