FDA.reportPublic FDA data

Halodine Nasal Antiseptic Swabstick

Manufacturer
Halodine LLC
Effective date
2020-10-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:31:21

Label at a glance#

ProductHalodine Nasal Antiseptic Swabstick
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 swabstick. Hold tube between thumb and forefinger at blue band with handle up. With other hand, hold handle at base, and bend to snap open. Bend and snap in opposite direction to disconnect swabstick. Remove swabstick from tube. Apply medication. Insert swabstick comfortably into right nostril. Do not insert swab more than 1/4” pas...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-Iodine USP, 2.5%

(0.25% 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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • Deep or puncture wounds
  • Serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 swabstick. Hold tube between thumb and forefinger at blue band with handle up. With other hand, hold handle at base, and bend to snap open. Bend and snap in opposite direction to disconnect swabstick. Remove swabstick from tube.
  3. Apply medication. Insert swabstick comfortably into right nostril. Do not insert swab more than 1/4” past nasal opening. Rotate swab within nostril for a total of 15 seconds, using a gentle swirling motion. Discard tube and swabstick.
  4. Repeat steps 2 and 3 with second swabstick for left nostril.

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

Other Information

SPL UNCLASSIFIED 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

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Halodine 301-01Halodine 301-01

Halodine 301-02Halodine 301-02

Halodine 301-12Halodine 301-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2390296povidone-iodine 2.5 % Medicated PadPSN2
2390296povidone-iodine 25 MG/ML Medicated PadSCD2
2390296povidone-iodine 2.5 % (titratable iodine 0.25 % ) Topical SwabSY2

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
78371-301-012022-01-28C16284748780-1d6a99b39-fd74-a426-e053-dadaa90af4c2Halodine Nasal Antiseptic Swabstick
78371-301-022022-01-28C16284748780-1d6a99b39-fd74-a426-e053-dadaa90af4c2Halodine Nasal Antiseptic Swabstick
78371-301-122022-01-28C16284748780-1d6a99b39-fd74-a426-e053-dadaa90af4c2Halodine Nasal Antiseptic Swabstick

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78371-301-01Halodine Nasal Antiseptic Swabstick100 in 1 CARTONSOLUTION1002
78371-301-01Halodine Nasal Antiseptic Swabstick0.5 mL in 1 TUBE, WITH APPLICATORSOLUTION0.52
78371-301-02Halodine Nasal Antiseptic Swabstick0.5 mL in 1 TUBE, WITH APPLICATORSOLUTION0.52
78371-301-02Halodine Nasal Antiseptic Swabstick6 in 1 BOXSOLUTION62
78371-301-12Halodine Nasal Antiseptic Swabstick20 in 1 CARTONSOLUTION202
78371-301-12Halodine Nasal Antiseptic Swabstick6 in 1 BOXSOLUTION62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78371-301HALODINE NASAL ANTISEPTIC SWABSTICK (POVIDONE-IODINE) SOLUTION [HALODINE LLC]2Legacy NDC, 6 package rows20201010_acd98be1-9472-188d-e053-2995a90a26e5.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
78371-30178371-301-01, 78371-301-02, 78371-301-12

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
57d65939-a034-4caf-b120-69b5b3661455acd98be1-9472-188d-e053-2995a90a26e52020-10-07WarningsExact identifier
spl id: 57d65939-a034-4caf-b120-69b5b3661455
spl set id: acd98be1-9472-188d-e053-2995a90a26e5

Reported adverse events (FAERS/openFDA)#

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