FDA.reportPublic FDA data

Stye Eye Relief

Manufacturer
Similasan AG
Effective date
2021-10-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:19:21

Label at a glance#

ProductStye Eye Relief
Active ingredientCONIUM MACULATUM FLOWERING TOP, GRAPHITE, SULFUR
Label structure13 sections

Indications and uses

According to homeopathic principles, the active ingredients in this medication temporarily relieve minor symptoms such as: redness burning eyelid redness tearing

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 3-4 times per day replace cap after use if desired, use with a warm, moistened washcloth placed directly on eyelid

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Conium maculatum 6X

Purpose

OTC - PURPOSE SECTION

redness

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Graphites 12X

Purpose

OTC - PURPOSE SECTION

eyelid redness

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sulphur 12X

Purpose

OTC - PURPOSE SECTION

tearing, burning

Uses:

INDICATIONS & USAGE SECTION

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

  • redness
  • burning
  • eyelid redness
  • tearing

Warnings:

WARNINGS SECTION

  • The purpose of this product is to provide temporary relief of stye symptoms, and is not a cure for styes.
  • For external use only.
  • 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.
  • †Our drops will not harm contact lenses, however we recommend not wearing contacts while experiencing eye irritation.

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
  • if condition is accompanied by fever

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
  • the stye enlarges
  • the style opens, draining discharge or pus into the eye

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 3-4 times per day
  • replace cap after use
  • if desired, use with a warm, moistened washcloth placed directly on eyelid

Other Information:

OTHER SAFETY INFORMATION

Active ingredients are manufactured according to homeopathic principles.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

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

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


Similasan
Stye Eye Relief
STERILE EYE DROPS
10 ml / 0.33 fl oz

Similasan Stye Eye Relief STERILE EYE DROPS 10 ml / 0.33 fl ozSimilasan Stye Eye Relief STERILE EYE DROPS 10 ml / 0.33 fl oz

Similasan Stye Eye Relief STERILE EYE DROPS 10 ml / 0.33 fl ozSimilasan Stye Eye Relief STERILE EYE DROPS 10 ml / 0.33 fl oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53799-305-112025-01-30C16284748780-12cef2736-9192-d83d-e063-dadaa90ab31fStye Eye Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53799-305-11Stye Eye Relief10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53799-305STYE EYE RELIEF (CONIUM MACULATUM FLOWERING TOP, GRAPHITE AND SULFUR) SOLUTION/ DROPS [SIMILASAN AG]4Legacy NDC, 1 package rows20230106_efa6354d-90af-4eb6-8311-6674c226dec3.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
53799-30553799-305-11

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
CONIUM MACULATUM FLOWERING TOPQ28R5GF371ACTIB
GRAPHITE4QQN74LH4OACTIB
SULFUR70FD1KFU70ACTIB
BORIC ACIDR57ZHV85D4IACT
WATER059QF0KO0RIACT
SILVER SULFATE8QG6HV4ZPOIACT
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
249ba992-b0e3-4edc-b16a-a50a689b29feefa6354d-90af-4eb6-8311-6674c226dec32021-10-07WarningsExact identifier
spl id: 249ba992-b0e3-4edc-b16a-a50a689b29fe
spl set id: efa6354d-90af-4eb6-8311-6674c226dec3

Reported adverse events (FAERS/openFDA)#

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