FDA.reportPublic FDA data

Allergy Eye Relief

Manufacturer
Similasan Corporation
Effective date
2021-10-06
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 02:19:18

Label at a glance#

ProductAllergy Eye Relief
Active ingredientAPIS MELLIFERA, EUPHRASIA STRICTA, SCHOENOCAULON OFFICINALE SEED
Label structure18 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 1-2 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.
  • †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

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 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.

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

NDC 59262-346-11
Similasan
Allergy Eye Relief
STERILE EYE DROPS
10 ml / 0.33 fl oz

NDC 59262-346-11 Similasan Allergy Eye Relief STERILE EYE DROPS 10 ml / 0.33 fl ozNDC 59262-346-11 Similasan Allergy Eye Relief STERILE EYE DROPS 10 ml / 0.33 fl oz

NDC 59262-346-11 Similasan Allergy Eye Relief STERILE EYE DROPS 10 ml / 0.33 fl ozNDC 59262-346-11 Similasan Allergy Eye Relief STERILE EYE DROPS 10 ml / 0.33 fl oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59262-346-112025-01-30C16284748780-12cef2736-5e8a-d83d-e063-dadaa90ab31fAllergy Eye Relief 10 ml

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59262-346-11Allergy Eye Relief10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS109

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59262-346ALLERGY EYE RELIEF (APIS MELLIFERA, EUPHRASIA STRICTA AND SCHOENOCAULON OFFICINALE SEED) SOLUTION/ DROPS [SIMILASAN CORPORATION]9Legacy NDC, 1 package rows20230106_87c00891-0de9-403f-bd5d-af8548586485.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59262-346-11ML - Milliliter59262-34601d5974a-989a-4029-b8fd-4844ee2f9c9f12015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
APIS MELLIFERAACTIVE INGREDIENT7S82P3R43Z5
EUPHRASIA STRICTAACTIVE INGREDIENTC9642I91WL5
SCHOENOCAULON OFFICINALE SEEDACTIVE INGREDIENT6NAF1689IO5
APIS MELLIFERAACTIVE MOIETY7S82P3R43Z5
EUPHRASIA STRICTAACTIVE MOIETYC9642I91WL5
SCHOENOCAULON OFFICINALE SEEDACTIVE MOIETY6NAF1689IO5
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D45
SILVER SULFATEINACTIVE INGREDIENT8QG6HV4ZPO5
SODIUM NITRATEINACTIVE INGREDIENT8M4L3H2ZVZ5
WATERINACTIVE INGREDIENT059QF0KO0R5

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
59262-34659262-346-11

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
SILVER SULFATE8QG6HV4ZPOIACT
SODIUM NITRATE8M4L3H2ZVZIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BORIC ACIDBORIC ACIDR57ZHV85D4SUSPENSION/ DROPS / AURICULAR (OTIC)3 mgExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS0.53 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SUSPENSION / AURICULAR (OTIC)0.6 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4INJECTION, SOLUTION / INTRAVENOUS210 mgExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION / OPHTHALMIC60 mgExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SUSPENSION/ DROPS / TOPICAL0.3 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4MOUTHWASH / BUCCAL7.36 mg/1mlExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.3 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4DROPS / OPHTHALMIC1 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4GEL / OPHTHALMIC0.5 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4EMULSION / OPHTHALMIC0.3 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4EMULSION / TOPICAL1.3 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SHAMPOO / TOPICAL2 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4JELLY / VAGINAL1 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SUSPENSION/ DROPS / OPHTHALMIC22 mgExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii candidate
17 equally ranked IID candidates
SODIUM NITRATESODIUM NITRATE8M4L3H2ZVZSOLUTION / OPHTHALMIC1.18 %w/wExact identifier — unii candidate

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
6b382327-892b-4c5a-87cb-c1956c56c30087c00891-0de9-403f-bd5d-af85485864852021-10-06WarningsExact identifier
spl id: 6b382327-892b-4c5a-87cb-c1956c56c300
spl set id: 87c00891-0de9-403f-bd5d-af8548586485

Reported adverse events (FAERS/openFDA)#

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