FDA.reportPublic FDA data

Allergy 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#

ProductAllergy Eye Relief
Active ingredientAPIS MELLIFERA, EUPHRASIA STRICTA, SCHOENOCAULON OFFICINALE SEED
Label structure14 sections

Indications and uses

According to homeopathic principles, the active ingredients in this product temporarily relieve minor eye allergy symptoms such as: itching       burning excessive watering redness of eyes and lids

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 2-3 drops into eye apply as needed replace cap after use

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Apis mellifica 6X

Purpose

OTC - PURPOSE SECTION

burning, itching, stinging

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Euphrasia officinalis (Eyebright) 6X

Purpose

OTC - PURPOSE SECTION

redness, swelling, watering

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sabadilla 6X

Purpose

OTC - PURPOSE SECTION

watering, redness of lids

Uses:

INDICATIONS & USAGE SECTION

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

  • itching      
  • burning
  • excessive watering
  • redness of eyes and lids

Warnings:

WARNINGS SECTION

  • For external use only.
  • According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).
  • Replace cap tightly after every use.
  • To avoid contamination, do not touch the plastic tip to any surface.
  • To avoid contamination use within 30 days of opening. Expiration date only refers to unopened bottle.
  • Contact wearers: consult a physician prior to using.

If pregnant, trying to get pregnant,

SPL UNCLASSIFIED SECTION

or breast feeding, 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:

  • remove tamper-evident seal from neck of bottle
  • twist cap off bottle
  • DON’T squeeze bottle, squeeze plastic tip to release 2-3 drops into eye
  • apply as needed
  • replace cap after use

Other Information:

OTHER SAFETY INFORMATION

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Borate buffer, Purified water, Silver sulfate (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

Allergy Eye Relief

STERILE EYE DROPS

10 ml / 0.33 fl oz

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53799-301-112025-01-30C16284748780-12cef2736-a528-d83d-e063-dadaa90ab31fAllergy Eye Relief Blue Image

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53799-301-11Allergy Eye Relief10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS103
53799-301-11Allergy Eye Relief1 in 1 BOXSOLUTION/ DROPS13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53799-301ALLERGY EYE RELIEF (APIS MELLIFERA, EUPHRASIA STRICTA, SCHOENOCAULON OFFICINALE SEED) SOLUTION/ DROPS [SIMILASAN AG]3Legacy NDC, 2 package rows20230106_01b8052d-3ce1-4e71-b4f4-1b701825cd60.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
53799-30153799-301-11

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
APIS MELLIFERA7S82P3R43ZACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
SCHOENOCAULON OFFICINALE SEED6NAF1689IOACTIB
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
b2baf22b-43da-4c6a-a1c2-a147e0730cfd01b8052d-3ce1-4e71-b4f4-1b701825cd602020-10-07WarningsExact identifier
spl id: b2baf22b-43da-4c6a-a1c2-a147e0730cfd
spl set id: 01b8052d-3ce1-4e71-b4f4-1b701825cd60

Reported adverse events (FAERS/openFDA)#

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