FDA.reportPublic FDA data

Dry Eye Relief

Manufacturer
Similasan AG
Effective date
2020-10-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:19:11

Label at a glance#

ProductDry Eye Relief
Active ingredientATROPA BELLADONNA, EUPHRASIA STRICTA, MERCURIC CHLORIDE
Label structure10 sections

Indications and uses

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as: • dry eye • redness of eyes and lids • reflex watering secondary to dry eye

Dosage and administration

For adults and children age 2 and over: • remove a single-use dropper • twist flat end with ball to remove • squeeze plastic dropper to release 2-3 drops into eye and discard applicator • apply as needed • use a new dropper for every application

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Belladonna† 6X

Euphrasia officinalis (Eyebright) 6X

Mercurius sublimatus 15X

Purpose

OTC - PURPOSE SECTION

dryness, redness

redness

dryness, watering

Uses*

INDICATIONS & USAGE SECTION

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:

• dry eye

• redness of eyes and lids

• reflex watering secondary to dry eye

Warnings

WARNINGS SECTION

• For external use only.

• According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).

• Use only if single-use dropper is intact.

• To avoid contamination, do not touch the tip of the dropper to any surface. Do not reuse. Once opened, discard.

• Contact lens wearers: consult a physician prior to using.

If pregnant, trying to get pregnant or breast feeding, ask a health professional before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

Do not use:

OTC - DO NOT USE SECTION

• if solution changes color or becomes cloudy

Stop use and ask a doctor if:

OTC - STOP USE SECTION

• symptoms worsen or persist for more than 72 hours

• you experience eye pain or changes in vision

Directions

DOSAGE & ADMINISTRATION SECTION

For adults and children age 2 and over:

• remove a single-use dropper

• twist flat end with ball to remove

• squeeze plastic dropper to release 2-3 drops into eye and discard applicator

• apply as needed

• use a new dropper for every application

Other Information

OTHER SAFETY INFORMATION

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Phosphate buffer, Purified water

Questions?

OTC - QUESTIONS SECTION

Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com

www.SimilasanUSA.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Dry Eye
Relief
0.4 ml/0.014 fl oz each

Dry Eye Relief 0.4 ml/0.014 fl oz eachDry Eye Relief 0.4 ml/0.014 fl oz each

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53799-300-122025-01-30C16284748780-12cef2736-a556-d83d-e063-dadaa90ab31fDry Eye Relief Monodose 15x

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53799-300-12Dry Eye Relief0.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.43
53799-300-12Dry Eye Relief20 in 1 CARTONSOLUTION/ DROPS203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53799-300DRY EYE RELIEF (ATROPA BELLADONNA AND EUPHRASIA STRICTA AND MERCURIC CHLORIDE) SOLUTION/ DROPS [SIMILASAN AG]3Legacy NDC, 2 package rows20230106_10962b03-2432-4efa-a020-d8edddd92763.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53799-30053799-300-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ATROPA BELLADONNAWQZ3G9PF0HACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
MERCURIC CHLORIDE53GH7MZT1RACTIB
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
WATER059QF0KO0RIACT

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
0e1c06e0-df5f-4a0c-894c-70f1517dc89110962b03-2432-4efa-a020-d8edddd927632020-10-07WarningsExact identifier
spl id: 0e1c06e0-df5f-4a0c-894c-70f1517dc891
spl set id: 10962b03-2432-4efa-a020-d8edddd92763

Reported adverse events (FAERS/openFDA)#

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