Label: HALODINE NASAL ANTISEPTIC- povidone-iodine spray

  • 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 February 4, 2021

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredient

    Povidone-Iodine USP, 1.25%

    (0.125% Available Iodine)

  • Purpose

    Antiseptic

  • Uses

    • Kills germs • Helps reduce bacteria that cause infections

  • 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

    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 to skin inside of nostrils in adults and children 3 years of age and older:

    1. Gently blow nose to clear both nostrils. Discard tissue.

    2. Remove cap.

    3. Close one nostril and put only the tip of spray nozzle in other nostril. Aim slightly away from center of nose.

    4. While sniffing gently, press down the spray nozzle twice. You'll feel a light mist in your nose. Breathe out through your mouth. 

    5. Repeat in other nostril. Wipe spray nozzle with clean tissue and replace cap.

    Children under 3 years of age: Consult a doctor.

  • Other Information

    • Not made with natural rubber latex • Store at room temperature; avoid excessive heat 

  • Inactive Ingredients

    hydroxyethylcellulose, purified water

  • Questions or comments?

    contact@halodine.com

  • SPL UNCLASSIFIED SECTION

    STOP VIRUSES BEFORE THEY SPREAD 

    Kills viruses and bacteria that cause infections 

    Kills the virus that causes COVID-19

    4 Hour Formula

    Inactivates the SARS-CoV-2 virus in less than 15 seconds

    Distributed by

    Halodine LLC

    111 NE 1st St

    Suite 806

    Miami, FL 33132

    Made in the U.S.A

    halodine.com

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    HALODINE NASAL ANTISEPTIC 
    povidone-iodine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78371-501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE1.25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78371-501-011 in 1 BOX02/01/2021
    115 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/01/2021
    Labeler - Halodine Llc (117526113)