FDA.reportPublic FDA data

Pink Eye Nighttime Gel

Manufacturer
Similasan Corporation
Effective date
2020-11-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:19:19

Label at a glance#

ProductPink Eye Nighttime
Active ingredientATROPA BELLADONNA, EUPHRASIA STRICTA, CALCIUM SULFIDE
Label structure14 sections

Indications and uses

According to homeopathic principles, the active ingredients in this product temporarily relieve minor eye symptoms: • excessive watery (clear) discharge • sensation of grittiness • redness and burning

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Belladonna 6X†

†containing 0.000002% alkaloids calculated as hyoscyamine

Purpose

OTC - PURPOSE SECTION

dryness, redness, burning, sensation of grittiness

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Euphrasia officinalis (Eyebright) 6X

Purpose

OTC - PURPOSE SECTION

watery discharge

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Hepar sulphuris 12X

Purpose

OTC - PURPOSE SECTION

redness, stinging

Uses*

INDICATIONS & USAGE SECTION

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

• excessive watery (clear) discharge

• sensation of grittiness

• redness and burning

Warnings

WARNINGS SECTION

• For external use only.

• 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 bottle 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 wearers: consult 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 the solution 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

• you might have a serious underlying medical cause for an infection

Directions

DOSAGE & ADMINISTRATION SECTION

For adults and children ages 2 and over:

• remove tamper-evident seal from neck of bottle

• twist cap off bottle

• DON’T squeeze bottle, squeeze plastic tip to release 1-2 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Borate buffer, Purified water, Silver sulfate (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

For your protection do not use if tamper evident seal around neck of bottle is missing or broken.

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 59262-377-11
Similasan
Pink eye

Nighttime
Gel™
10 mL/ 0.33 fl oz

NDC 59262-377-11 Similasan Pink eye Nighttime Gel™ 10 mL/ 0.33 fl ozNDC 59262-377-11 Similasan Pink eye Nighttime Gel™ 10 mL/ 0.33 fl oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59262-377-112025-01-30C16284748780-12cef2736-5d9a-d83d-e063-dadaa90ab31fPink Eye Nighttime Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59262-377-11Pink Eye Nighttime1 in 1 CARTONGEL12
59262-377-11Pink Eye Nighttime10 mL in 1 BOTTLE, DROPPERGEL102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59262-377PINK EYE NIGHTTIME (BELLADONNA, EUPHRASIA OFFICINALIS, HEPAR SULPHURIS) GEL [SIMILASAN CORPORATION]2Legacy NDC, 2 package rows20230106_bdbf0497-c7af-4c45-bdba-2c4d39c9b937.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
59262-37759262-377-11

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
CALCIUM SULFIDE1MBW07J51QACTIB
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
8d22a90e-f0ed-4d3e-876d-54440123255cbdbf0497-c7af-4c45-bdba-2c4d39c9b9372020-11-10WarningsExact identifier
spl id: 8d22a90e-f0ed-4d3e-876d-54440123255c
spl set id: bdbf0497-c7af-4c45-bdba-2c4d39c9b937

Reported adverse events (FAERS/openFDA)#

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