Halodine Oral Rinse

Manufacturer
Halodine LLC
Effective date
2020-11-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:33:44

Label at a glance#

ProductHalodine Oral Rinse
Active ingredientPOVIDONE-IODINE
Label structure10 sections

Indications and uses

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

Dosage and administration

For oral antisepsis in adults and children 3 years of age and older: Twist off the narrow end of single ampoule. Empty contents of ampoule into small cup. Add twice the amount of water to cup for total fill of 10 ml. Pour contents of cup into mouth. Swish vigorously in mouth for 15 seconds. Slightly lift chin and tilt head back to gargle, then spit out. Children under 3 years of age: Consult a dentist or doctor

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, 1.75%

(0.175% Available Iodine)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

When using this product: Do not swallow

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For oral antisepsis in adults and children 3 years of age and older:

  1. Twist off the narrow end of single ampoule.
  2. Empty contents of ampoule into small cup. Add twice the amount of water to cup for total fill of 10 ml.
  3. Pour contents of cup into mouth. Swish vigorously in mouth for 15 seconds.
  4. Slightly lift chin and tilt head back to gargle, then spit out.

Children under 3 years of age: Consult a dentist or doctor

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 Antiseptic Solution

PATENT PENDING

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
2380869povidone-iodine 1.75 % Topical SolutionPSN3
2380869povidone-iodine 17.5 MG/ML Topical SolutionSCD3
2380869povidone-iodine 1.75 % (titratable iodine 0.175 % ) 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
78371-201-012022-01-28C16284748780-1d6a99b39-7ee8-a426-e053-dadaa90af4c2Halodine Oral Rinse
78371-201-022022-01-28C16284748780-1d6a99b39-7ee8-a426-e053-dadaa90af4c2Halodine Oral Rinse
78371-201-032022-01-28C16284748780-1d6a99b39-7ee8-a426-e053-dadaa90af4c2Halodine Oral Rinse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78371-201-01Halodine Oral Rinse3.2 mL in 1 AMPULESOLUTION3.23
78371-201-01Halodine Oral Rinse100 in 1 CARTONSOLUTION1003
78371-201-02Halodine Oral Rinse3.8 mL in 1 AMPULESOLUTION3.83
78371-201-02Halodine Oral Rinse200 in 1 CARTONSOLUTION2003
78371-201-03Halodine Oral Rinse10 in 1 CARTONSOLUTION103
78371-201-03Halodine Oral Rinse3.2 mL in 1 AMPULESOLUTION3.23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78371-201HALODINE ORAL RINSE (POVIDONE-IODINE) SOLUTION [HALODINE LLC]3Legacy NDC, 6 package rows20201117_a9ee4c33-4a5b-3a1f-e053-2995a90aa515.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
78371-20178371-201-03, 78371-201-01, 78371-201-02

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
1100b895-e9b7-42f9-b787-c41d102e92a5a9ee4c33-4a5b-3a1f-e053-2995a90aa5152020-11-13WarningsExact identifier
spl id: 1100b895-e9b7-42f9-b787-c41d102e92a5
spl set id: a9ee4c33-4a5b-3a1f-e053-2995a90aa515

Reported adverse events (FAERS/openFDA)#

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