FDA.reportPublic FDA data

REMEDI Health Solutions

Manufacturer
Chc Montana
Effective date
2024-11-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:47:53

Label at a glance#

ProductREMEDI Health Solutions IRRITABLE EYE Relief
Active ingredientALUMINUM OXIDE, AMYL NITRITE, SILVER NITRATE, ARSENIC TRIIODIDE, CALENDULA OFFICINALIS FLOWERING TOP, CONIUM MACULATUM FLOWERING TOP, EUPHRASIA STRICTA, PHYSOSTIGMA VENENOSUM SEED, RUTA GRAVEOLENS FLOWERING TOP
Label structure9 sections

Indications and uses

Diminishes red, irritated, itchy dry eyes, discharge, eye fatigue, reading and computer strain.

Dosage and administration

Spray orally into mouth up to 2 times in the morning, and up to 2 times at night. May use this remedy as needed for eye fatigue. Discontinue if not satisfied after 30 days.

Label contents#

Full prescribing information#

HPUS Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

ALUMINUM OXIDE 6c

AMYLENUM NITROSUM 6c

ARGENTUM NITRICUM 6c

ARSENICUM IODATUM 6c

CALENDULA OFFICINALIS 6c,30c 

CONIUM MACULATUM 6c

EUPHRASIA OFFICINALIS 6c 

PHYSOSTIGMA VENENOSUM 6c

RUTA GRAVEOLENS 6c, 30c

Purpose

OTC - PURPOSE SECTION

ALUMINUM OXIDE 6c........................ Dryness, lids, squinty, sticky

AMYLENUM NITROSUM 6c...................Sun irritation, blurry, protruded

ARGENTUM NITRICUM 6c......... ..........Red, excess, mucus, dim vision

ARSENICUM IODATUM 6c....................Sore around eyes, ulcerated

CALENDULA OFFICINALIS 6c,30c......... Injuries, scratched cornea

CONIUM MACULATUM 6c.....................Drooping lids, light sensitive

EUPHRASIA OFFICINALIS 6c................Burning, inflammation, scarring

PHYSOSTIGMA VENENOSUM 6c.................Increased pressure & spasms

RUTA GRAVEOLENS 6c, 30c.......................Fatigued, tired, strained

USES

INDICATIONS & USAGE SECTION

Diminishes red, irritated, itchy dry eyes, discharge, eye fatigue, reading and computer strain.

WARNINGS

WARNINGS SECTION

Do not use if seal is broken or missing.

As with any drug, ask a doctor before use if pregnant or breastfeeding. This formula is highly diluted homeopathic and is generally safe for all ages. Call your provider if symptoms worsen after 7 days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medication out of the reach of children. In case of accidental overdose contact a medical professional or Poison Control Center immediately. The active homeopathic ingredients are diluted beyond 1 part per million.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Spray orally into mouth up to 2 times in the morning, and up to 2 times at night. May use this remedy as needed for eye fatigue. Discontinue if not satisfied after 30 days.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aqua, Deionized Water, Glycerin, Potassium Sorbate, Sodium Benzoate

Questions/Comments? Side Effects?

OTC - QUESTIONS SECTION

TOLL FREE: Call 855 - 777 - 5875

SPL UNCLASSIFIED SECTION

Authentic Time-Tested Health Products

Diminish red, irritated itchy, dry eyes

ORAL USE! NO EYE STRESS!

Homeopathic remedies have been effective and safe for over 200 years.

SUGAR FREE
DAIRY FREE
SOY FREE
GLUTEN FREE
NON-GMO

Customers love this product!

SATISFACTION GUARANTEED

Fast acting for dry, tired, red eyes. Add clarity to your vision.

No known drug interactions

HIGH POTENCY
FASTER ACTING

100% Natural • 100% Drug Free
Fast Acting • Zero Side Effects
Safe for All Ages

HOMEOPATHELLENSTURBO®
PO Box 6
Stevensville, MT 59870
Since 1993
Toll Free (855) 777-5875
RemediHealthSolutions.com

Manufactured by: PURE SOURCE LLC
9750 NW17th St., Miami, FL 33172

NDC# 5998531032

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IrrEyeIrrEye

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59985-310-322024-12-03C16284748780-1f386c64a-03e4-0266-e053-dadaa90a7c1aREMEDI Health Solutions-IRRITABLE EYE Relief
59985-310-322023-01-30C16284748780-1f386c64a-03e4-0266-e053-dadaa90a7c1aREMEDI Health Solutions-IRRITABLE EYE Relief

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59985-310REMEDI HEALTH SOLUTIONS IRRITABLE EYE RELIEF (ALUMINUM OXIDE, AMYLENUM NITROSUM, ARGENTUM NITRICUM, ARSENICUM IODATUM, CALENDULA OFFICINALIS, CONIUM MACULATUM, EUPHRASIA OFFICINALIS, PHYSOSTIGMA VENENOSUM, RUTA GRAVEOLENS) SPRAY [CHC MONTANA]4Legacy NDC20241205_e931de06-9d2f-45d9-8350-ce7205fb50e0.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59985-31059985-310-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALUMINUM OXIDELMI26O6933ACTIB
AMYL NITRITE22T8Z09XAKACTIB
SILVER NITRATE95IT3W8JZEACTIB
ARSENIC TRIIODIDE3029988O2TACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
CONIUM MACULATUM FLOWERING TOPQ28R5GF371ACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
PHYSOSTIGMA VENENOSUM SEEDCJV9E9IIOAACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT

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
6fa11662-d4a3-41d6-bdfb-09911a66d199e931de06-9d2f-45d9-8350-ce7205fb50e02025-05-30WarningsExact identifier
spl set id: e931de06-9d2f-45d9-8350-ce7205fb50e0

Reported adverse events (FAERS/openFDA)#

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