FDA.reportPublic FDA data

Halodine Nasal Antiseptic

Manufacturer
Halodine LLC
Effective date
2021-06-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:40:49

Label at a glance#

ProductHalodine Nasal Antiseptic
Active ingredientPOVIDONE-IODINE
Label structure10 sections

Indications and uses

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

Dosage and administration

For nasal application Gently blow nose to clear both nostrils. Discard tissue. Open single ampoule by folding the narrow end along line. To avoid spill while opening, maintain ampoule with narrow end pointing up. 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. Open second...

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-Iodine USP, 1.25%

(0.125% Available Iodine)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

hydroxyethylcellulose, purified water

Questions or comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitleduntitled

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2380867povidone-iodine 1.25 % Topical SolutionPSN3
2380867povidone-iodine 12.5 MG/ML Topical SolutionSCD3
2380867povidone-iodine 1.25 % (titratable iodine 0.125 % ) Topical SolutionSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78371-101-012022-07-29C16284748780-1e4f33bdf-b09f-d8a0-e053-dadaa90a6e4eHalodine Nasal Antiseptic
78371-101-032022-07-29C16284748780-1e4f33bdf-b09f-d8a0-e053-dadaa90a6e4eHalodine Nasal Antiseptic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78371-101-01Halodine Nasal Antiseptic1.5 mL in 1 AMPULESOLUTION1.53
78371-101-01Halodine Nasal Antiseptic96 in 1 CARTONSOLUTION963
78371-101-03Halodine Nasal Antiseptic12 in 1 CARTONSOLUTION123
78371-101-03Halodine Nasal Antiseptic1.5 mL in 1 AMPULESOLUTION1.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78371-101HALODINE NASAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION [HALODINE LLC]3Legacy NDC, 4 package rows20210615_a9dd7e56-1a97-5f0b-e053-2995a90a43bf.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78371-10178371-101-03, 78371-101-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
WATER059QF0KO0RIACT
POVIDONE-IODINE85H0HZU99MACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2ef9bb32-8fc1-4d9f-93ba-e04956091811a9dd7e56-1a97-5f0b-e053-2995a90a43bf2021-06-14WarningsExact identifier
spl id: 2ef9bb32-8fc1-4d9f-93ba-e04956091811
spl set id: a9dd7e56-1a97-5f0b-e053-2995a90a43bf

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.