FDA.reportPublic FDA data

Dry Eye Nighttime Gel

Manufacturer
Similasan AG
Effective date
2022-01-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:15:38

Label at a glance#

ProductDry Eye Nighttime
Active ingredientATROPA BELLADONNA, EUPHRASIA STRICTA, MERCURIC CHLORIDE
Label structure13 sections

Indications and uses

According to homeopathic principles, the active ingredients in this medication 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 tamper-evident seal from neck of bottle twist cap off bottle DON’T squeeze bottle, squeeze plastic tip to release 1 to 2 drops into eye apply as needed replace cap after use

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Belladonna* 6X

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

Uses:

INDICATIONS & USAGE SECTION

According to homeopathic principles, the active ingredients in this medication 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 (in the eye).
  • Children under 2 years of age should be seen by a physician.
  • According to homeopathic principles, symptoms may temporarily worsen before improving (initial exacerbation of symptoms).
  • To avoid contamination, do not touch the tip of the container to any surface.
  • To avoid contamination use within 30 days of opening. Expiration date only refers to unopened bottle.
  • Replace cap tightly after every use.
  • Contact lens wearers: consult 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 gel changes color or becomes cloudy

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • you experience eye pain or changes in vision
  • symptoms worsen or persist for more than 72 hours

Directions:

DOSAGE & ADMINISTRATION SECTION

For adults and children age 2 and over:

  • remove tamper-evident seal from neck of bottle
  • twist cap off bottle
  • DON’T squeeze bottle, squeeze plastic tip to release 1 to 2 drops into eye
  • apply as needed
  • replace cap after use

Other Information:

OTHER SAFETY INFORMATION

  • Active ingredients are manufactured according to homeopathic principles.
  • Store below 86° F / 30° C

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Borate buffer, Purified water, Silver sulphate (as preservative), Sodium hyaluronate, Sodium nitrate

Questions?

OTC - QUESTIONS SECTION

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

*containing ≤0.000002% alkaloids calculated as hyoscyamine

Principle Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Similasan
Dry Eye Nighttime Gel
Sterile Gel Eye Drops
10 ml / 0.33 fl oz

Similasan Dry Eye Nighttime Gel Sterile Gel Eye Drops 10 ml / 0.33 fl ozSimilasan Dry Eye Nighttime Gel Sterile Gel Eye Drops 10 ml / 0.33 fl oz

Similasan Dry Eye Nighttime Gel Sterile Gel Eye Drops 10 ml / 0.33 fl ozSimilasan Dry Eye Nighttime Gel Sterile Gel Eye Drops 10 ml / 0.33 fl oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53799-378-112024-01-30C16284748780-11030e365-6278-111a-e063-dadaa90a10e2Dry Eye Nighttime Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53799-378-11Dry Eye Nighttime1 in 1 CARTONGEL11
53799-378-11Dry Eye Nighttime10 mL in 1 BOTTLE, DROPPERGEL101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53799-378DRY EYE NIGHTTIME (ATROPA BELLADONNA, EUPHRASIA STRICTA AND MERCURIC CHLORIDE) GEL [SIMILASAN AG]1Legacy NDC, 2 package rows20220125_67b45b8e-6bfe-47c6-8d68-de27056c4dcb.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53799-37853799-378-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ATROPA BELLADONNAWQZ3G9PF0HACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
MERCURIC CHLORIDE53GH7MZT1RACTIB
WATER059QF0KO0RIACT
SILVER SULFATE8QG6HV4ZPOIACT
HYALURONATE SODIUMYSE9PPT4THIACT
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
b7dd4f10-a340-4149-b9c2-7a507eb7fb6d67b45b8e-6bfe-47c6-8d68-de27056c4dcb2022-01-20WarningsExact identifier
spl id: b7dd4f10-a340-4149-b9c2-7a507eb7fb6d
spl set id: 67b45b8e-6bfe-47c6-8d68-de27056c4dcb

Reported adverse events (FAERS/openFDA)#

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