Label: HALODINE NASAL ANTISEPTIC- povidone-iodine solution

  • 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 August 14, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Povidone-Iodine USP, 1.25%

    (0.125% Available Iodine)

  • Purpose

    Antiseptic

  • Uses

    • Antiseptic skin preparation
    • Helps reduce bacteria that can potentially cause skin infection
  • Warnings

    For external use only.

    Do not use

    • If allergic to iodine
    • In the eyes
    • On children less than 3 years old
    • Over large areas of the body

    Ask a doctor before use if injuries are

    • Deep or puncture wounds
    • Serious burns

    Stop use and ask a doctor if

    irritation and redness develop or if condition persists for more than 72 hours.

    Keep out of reach of children.

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

  • Directions

    For nasal application

    1. Gently blow nose to clear both nostrils. Discard tissue.
    2. Open single ampoule by tearing off the narrow end along line. To avoid spill while opening, only hold flat foil around raised body of ampoule and maintain ampoule with narrow end pointing up.
    3. Place narrow end of ampoule at right nostril and gently pinch left nostril. Lift chin and tilt head back; squeeze all liquid from ampoule while inhaling through right nostril. Discard ampoule.
    4. Open second ampoule by tearing off the narrow end along line. Avoid spill.
    5. Place narrow end of ampoule at left nostril and gently pinch right nostril. Lift chin and tilt head back; squeeze all liquid from ampoule while inhaling through left nostril. Discard ampoule.

    Note: Do not blow nose. If solution drips, wipe with tissue.

  • Other Information

    • Single use only; do not reuse
    • Not made with natural rubber latex
    • Store at room temperature; avoid excessive heat
  • Inactive Ingredients

    hydroxyethylcellulose, purified water

  • Questions or comments?

    contact@halodine.com

  • Principal Display Panel

    Halodine 101.02

  • INGREDIENTS AND APPEARANCE
    HALODINE NASAL ANTISEPTIC 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78371-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE1.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78371-101-02100 in 1 CARTON06/15/2020
    11.5 mL in 1 AMPULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/15/2020
    Labeler - Halodine LLC (117526113)
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