FDA.reportPublic FDA data

Dry Eye Relief Trial Size 15x

Manufacturer
Similasan Corporation
Effective date
2021-07-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:19:14

Label at a glance#

ProductDry Eye Relief Trial Size 15x
Active ingredientATROPA BELLADONNA, EUPHRASIA STRICTA, MERCURIC CHLORIDE
Label structure12 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: twist flat end with ball to open squeeze plastic dropper to release 2-3 drops into eye and discard applicator apply as needed

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Dry Eye Relief Trial Size

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Belladonna* 6X

*containing 0.000002% alkaloids calculated as hyoscyamine.

Purpose

OTC - PURPOSE SECTION

dryness, redness

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Euphrasia officinalis (Eyebright) 6X

Purpose

OTC - PURPOSE SECTION

redness

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Mercurius sublimatus 15X

Purpose

OTC - PURPOSE SECTION

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 wearers: consult a physician prior to using.

If pregnant, trying to get pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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 the 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:

  • twist flat end with ball to open
  • squeeze plastic dropper to release 2-3 drops into eye and discard applicator
  • apply as needed

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Phosphate buffer, Purified water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 59262-376-13
Similasan
Dry Eye
Relief
SINGLE-USE STERILE EYE DROPS
Preservative Free
0.4 ml/ 0.014 fl oz (one vial)


Principal Display Panel NDC 59262-376-13 Similasan Dry Eye Relief SINGLE-USE STERILE EYE DROPS Preservative Free 0.4 ml/ 0.014 fl oz (one vial)Principal Display Panel NDC 59262-376-13 Similasan Dry Eye Relief SINGLE-USE STERILE EYE DROPS Preservative Free 0.4 ml/ 0.014 fl oz (one vial)
Principal Display Panel NDC 59262-376-13 Similasan Dry Eye Relief SINGLE-USE STERILE EYE DROPS Preservative Free 0.4 ml/ 0.014 fl oz (one vial)Principal Display Panel NDC 59262-376-13 Similasan Dry Eye Relief SINGLE-USE STERILE EYE DROPS Preservative Free 0.4 ml/ 0.014 fl oz (one vial)
Principal Display Panel NDC 59262-376-13 Similasan Dry Eye Relief SINGLE-USE STERILE EYE DROPS Preservative Free 0.4 ml/ 0.014 fl oz (one vial)Principal Display Panel NDC 59262-376-13 Similasan Dry Eye Relief SINGLE-USE STERILE EYE DROPS Preservative Free 0.4 ml/ 0.014 fl oz (one vial)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59262-376-132025-01-30C16284748780-12cef2736-9109-d83d-e063-dadaa90ab31fDry Eye Relief Trial Size 15x

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59262-376-13Dry Eye Relief Trial Size 15x.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS.42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59262-376DRY EYE RELIEF TRIAL SIZE 15X (BELLADONNA, EUPHRASIA OFFICINALIS, MERCURIUS SUBLIMATUS,) SOLUTION/ DROPS [SIMILASAN CORPORATION]2Legacy NDC, 1 package rows20230106_731a668e-facc-4be6-95d5-eb2907005312.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59262-37659262-376-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ATROPA BELLADONNAWQZ3G9PF0HACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
MERCURIC CHLORIDE53GH7MZT1RACTIM
WATER059QF0KO0RIACT
SODIUM NITRATE8M4L3H2ZVZIACT

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
57bc88f1-8161-4dae-a023-069eebe7083f731a668e-facc-4be6-95d5-eb29070053122021-07-12WarningsExact identifier
spl id: 57bc88f1-8161-4dae-a023-069eebe7083f
spl set id: 731a668e-facc-4be6-95d5-eb2907005312

Reported adverse events (FAERS/openFDA)#

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