Halodine Oral Antiseptic Spray

Manufacturer
Halodine Llc
Effective date
2020-10-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:31:41

Label at a glance#

ProductHalodine Oral Antiseptic
Active ingredientPOVIDONE-IODINE
Label structure10 sections

Storage and handling

Other Information  • 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

INDICATIONS & USAGE SECTION

Uses • Oral Antiseptic • First aid to help prevent infection in minor oral irritation caused by dental procedures

WARNINGS SECTION

Warnings For external use only.

Do not use • If allergic to iodine • In the eyes • On children less than 3 years old • For more than 7 days unless directed by a dentist or doctor Stop use and promptly ask your dentist or doctor if sore mouth symptoms do not improve within 7 days, if irritation, pain, or redness persists or worsens, or if swelling, rash, or fever develops.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions For oral antisepsis in adults and children 3 years of age and older:
1. Press down pump completely and spray twice into mouth. 2. Swish vigorously in mouth for 15 seconds. 3. Slightly lift chin and tilt head back to gargle. Spit out excess. Children under 3 years of age: Consult a dentist or doctor

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients hydroxyethylcellulose, purified water

OTC - QUESTIONS SECTION

Questions or comments? contact@halodine.com

SPL UNCLASSIFIED SECTION

Povidone-Iodine USP, 1.25%

Helps Reduce Risk of Infection

4-Hour Formula

halodine.com

PATENT PENDING

Manufactured in the U.S.A.

for Halodine LLC 111 NE 1st St,

Ste 806, Miami, FL 33132

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2400034povidone-iodine 1.25 % Mucosal SprayPSN1
2400034povidone-iodine 12.5 MG/ML Mucosal SpraySCD1
2400034povidone-iodine 1.25 % (titratable iodine 0.125 % ) Mucosal SpraySY1
2400034povidone-iodine 1.25 % Mucosal SpraySY1

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
78371-401-012022-01-28C16284748780-1d6a99b39-fd53-a426-e053-dadaa90af4c2Halodine Oral Antiseptic Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78371-401-01Halodine Oral Antiseptic60 mL in 1 BOTTLE, SPRAYSPRAY601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78371-401HALODINE ORAL ANTISEPTIC (POVIDONE-IODINE) SPRAY [HALODINE LLC]1Legacy NDC, 1 package rows20201016_0c834b76-f367-4550-9b4e-82ade5df7094.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
78371-40178371-401-01

Ingredients#

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

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

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
2ca898e7-199b-487d-802d-b662ab2a2db20c834b76-f367-4550-9b4e-82ade5df70942020-10-14WarningsExact identifier
spl id: 2ca898e7-199b-487d-802d-b662ab2a2db2
spl set id: 0c834b76-f367-4550-9b4e-82ade5df7094

Reported adverse events (FAERS/openFDA)#

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