Label: HALODINE NASAL ANTISEPTIC- povidone-iodine solution

  • NDC Code(s): 78371-101-01, 78371-101-03
  • Packager: Halodine LLC
  • 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 November 13, 2020

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

    • 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 folding the narrow end along line. To avoid spill while opening, 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 folding 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

  • SPL UNCLASSIFIED SECTION

    HELPS REDUCE RISK OF INFECTION •  4-HOUR FORMULA

    Non-sterile Solution

    Manufactured in the U.S.A. for Halodine LLC

    111 NE 1st St, Ste 806, Miami, FL 33132

    halodine.com

  • Packaging

    untitled

  • 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:78371-101-0312 in 1 CARTON10/28/2020
    11.5 mL in 1 AMPULE; Type 0: Not a Combination Product
    2NDC:78371-101-0196 in 1 CARTON05/15/2020
    21.5 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 finalpart333E05/15/2020
    Labeler - Halodine LLC (117526113)