FDA.reportPublic FDA data

Redness and Itchy Eye Relief

Manufacturer
Similasan Corporation | Similasan AG
Effective date
2021-10-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:15:00

Label at a glance#

ProductRedness and Itchy Eye Relief
Active ingredientAPIS MELLIFERA, EUPHRASIA STRICTA, PULSATILLA VULGARIS, SCHOENOCAULON OFFICINALE SEED
Label structure20 sections

Indications and uses

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

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#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Apis mellifica 6X

Purpose

OTC - PURPOSE SECTION

stinging, burning, itching

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Euphrasia officinalis (Eyebright) 6X

Purpose

OTC - PURPOSE SECTION

redness, irritation

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Pulsatilla 6X

Purpose

OTC - PURPOSE SECTION

itching, burning, redness, 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 symptoms such as:

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

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 tip of the container to any surface.
  • 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 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

  • changes in vision occur
  • you experience eye pain
  • 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.

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 59262-363-11
Similasan®
Redness &
Itchy Eye
Relief
STERILE
EYE DROPS
10 mL/0.33 fl oz

PRINCIPAL DISPLAY PANEL NDC 59262-363-11 Similasan® Redness & Itchy Eye Relief STERILE EYE DROPS 10 mL/0.33 fl ozPRINCIPAL DISPLAY PANEL NDC 59262-363-11 Similasan® Redness & Itchy Eye Relief STERILE EYE DROPS 10 mL/0.33 fl oz

PRINCIPAL DISPLAY PANEL NDC 59262-363-11 Similasan® Redness & Itchy Eye Relief STERILE EYE DROPS 10 mL/0.33 fl ozPRINCIPAL DISPLAY PANEL NDC 59262-363-11 Similasan® Redness & Itchy Eye Relief STERILE EYE DROPS 10 mL/0.33 fl oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59262-363-112023-01-30C16284748780-19d75b9d0-f84a-f424-e053-dadaa90a57ceRedness and Itchy Eye Relief
59262-363-112020-09-28C16284748780-19d75b9d0-f84a-f424-e053-dadaa90a57ceRedness and Itchy Eye Relief
59262-363-112020-01-31C16284748780-19d75b9d0-f84a-f424-e053-dadaa90a57ceRedness and Itchy Eye Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59262-363-11Redness and Itchy Eye Relief10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS103
59262-363-11Redness and Itchy Eye Relief1 in 1 BOXSOLUTION/ DROPS13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59262-363REDNESS AND ITCHY EYE RELIEF (APIS MELLIFERA, EUPHRASIA STRICTA, PULSATILLA VULGARIS AND SCHOENOCAULON OFFICINALE SEED) SOLUTION/ DROPS [SIMILASAN CORPORATION]3Legacy NDC, 2 package rows20211005_accc81ae-ec9b-4e7c-9c1f-e2e1f54af290.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59262-363-11ML - Milliliter59262-36369f081ef-d8fd-466e-a2df-6a90dbf9449d12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
APIS MELLIFERAACTIVE INGREDIENT7S82P3R43Z1
EUPHRASIA STRICTAACTIVE INGREDIENTC9642I91WL1
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEV1
SCHOENOCAULON OFFICINALE SEEDACTIVE INGREDIENT6NAF1689IO1
APIS MELLIFERAACTIVE MOIETY7S82P3R43Z1
EUPHRASIA STRICTAACTIVE MOIETYC9642I91WL1
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEV1
SCHOENOCAULON OFFICINALE SEEDACTIVE MOIETY6NAF1689IO1
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D41
SILVER SULFATEINACTIVE INGREDIENT8QG6HV4ZPO1
SODIUM NITRATEINACTIVE INGREDIENT8M4L3H2ZVZ1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
59262-36359262-363-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
APIS MELLIFERA7S82P3R43ZACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
SCHOENOCAULON OFFICINALE SEED6NAF1689IOACTIB
BORIC ACIDR57ZHV85D4IACT
WATER059QF0KO0RIACT
SILVER SULFATE8QG6HV4ZPOIACT
SODIUM NITRATE8M4L3H2ZVZIACT

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 ACIDR57ZHV85D4SOLUTION / AURICULAR (OTIC)0.05 %w/wExact 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/ DROPS / AURICULAR (OTIC)3 mgExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SHAMPOO / TOPICAL2 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
SODIUM NITRATESODIUM NITRATE8M4L3H2ZVZSOLUTION / OPHTHALMIC1.18 %w/wExact identifier — unii candidate
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact 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 ACIDR57ZHV85D4SUSPENSION / AURICULAR (OTIC)0.6 %w/vExact 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 ACIDR57ZHV85D4SUSPENSION/ DROPS / TOPICAL0.3 %w/vExact 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 ACIDR57ZHV85D4MOUTHWASH / BUCCAL7.36 mg/1mlExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4DROPS / OPHTHALMIC1 %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 ACIDR57ZHV85D4JELLY / VAGINAL1 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION / OPHTHALMIC60 mgExact 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 ACIDR57ZHV85D4INJECTION, SOLUTION / INTRAVENOUS210 mgExact identifier — unii candidate
17 equally ranked IID candidates

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
89188c59-6540-485a-b150-2e732fc12019accc81ae-ec9b-4e7c-9c1f-e2e1f54af2902021-10-07WarningsExact identifier
spl id: 89188c59-6540-485a-b150-2e732fc12019
spl set id: accc81ae-ec9b-4e7c-9c1f-e2e1f54af290

Reported adverse events (FAERS/openFDA)#

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