FDA.reportPublic FDA data

Dry Eye Relief

Manufacturer
Similasan Corporation
Effective date
2011-01-20
Label type
HUMAN OTC DRUG LABEL
Version
21
Source
full-release
Hydrated at
2026-06-01 02:06:39

Label at a glance#

ProductDry Eye Relief
Active ingredientATROPA BELLADONNA, EUPHRASIA STRICTA, MERCURIC CHLORIDE
Label structure17 sections

Indications and uses

According to homeopathic principles, the active ingredients in this medication temporarily relieve minor symptoms such as: dry eye redness of eyes and lids reflex watering secondary to dry eye sensation of grittiness sensitivity to light

Dosage and administration

For adults and children age 2 and over: remove tamper-evident seal from neck of bottle twist cap off bottle squeeze plastic tip to release 2-3 drops into eye apply as needed replace cap after use

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Belladonna* 6X
*containing 0.000002% alkaloids calculated as hyoscyamine

Purpose

OTC - PURPOSE SECTION

dryness, redness

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Euphrasia 6X

Purpose

OTC - PURPOSE SECTION

redness

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Mercurius sublimatus 6X

Purpose

OTC - PURPOSE SECTION

dryness

Uses:

INDICATIONS & USAGE SECTION

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

  • dry eye
  • redness of eyes and lids
  • reflex watering secondary to dry eye
  • sensation of grittiness
  • sensitivity to light

Warnings:

WARNINGS SECTION

  • For external use only.
  • Initial exacerbation of symptoms may occur.
  • 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.
  • Contact wearers: consult a physician prior to using.

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 - ASK DOCTOR SECTION

  • symptoms worsen or persist for more than 72 hours
  • changes in vision occur
  • you experience eye pain

Directions:

DOSAGE & ADMINISTRATION SECTION

For adults and children age 2 and over:

  • remove tamper-evident seal from neck of bottle
  • twist cap off bottle
  • squeeze plastic tip to release 2-3 drops into eye
  • apply as needed
  • replace cap after use

Other Information:

INFORMATION FOR OWNERS/CAREGIVERS SECTION

Active ingredients are manufactured according to homeopathic principles and are therefore non-toxic and have no known side effects

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

Principle Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 59262-345-11
Similasan
Dry Eye Relief
Sterile Eye Drops
10 ml / 0.33 fl oz

NDC 59262-345-11 Similasan Dry Eye Relief Sterile Eye Drops 10 ml / 0.33 fl oz
NDC 59262-345-11 Similasan Dry Eye Relief Sterile Eye Drops 10 ml / 0.33 fl oz


FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59262-345-112020-01-31C16284748780-19d75b9cf-d6d6-f424-e053-dadaa90a57ceDry Eye Relief 10 ml

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59262-345-11Dry Eye Relief10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59262-345DRY EYE RELIEF (ATROPA BELLADONNA, EUPHRASIA STRICTA AND MERCURIC CHLORIDE) SOLUTION/ DROPS [SIMILASAN CORPORATION]21Legacy NDC, 1 package rows20150401_5475b6ea-7df2-446c-8df1-75879f389a89.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59262-345-11ML - Milliliter59262-345a8df4107-aec4-4614-9024-5ca7545a0d3412015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H21
EUPHRASIA STRICTAACTIVE INGREDIENTC9642I91WL21
MERCURIC CHLORIDEACTIVE INGREDIENT53GH7MZT1R21
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H21
EUPHRASIA STRICTAACTIVE MOIETYC9642I91WL21
MERCURIC CATIONACTIVE MOIETYED30FJ8Y4221
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D421
SILVER SULFATEINACTIVE INGREDIENT8QG6HV4ZPO21
SODIUM NITRATEINACTIVE INGREDIENT8M4L3H2ZVZ21
WATERINACTIVE INGREDIENT059QF0KO0R21

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
59262-34559262-345-11

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
MERCURIC CHLORIDE53GH7MZT1RACTIB
SODIUM NITRATE8M4L3H2ZVZIACT
BORIC ACIDR57ZHV85D4IACT
SILVER SULFATE8QG6HV4ZPOIACT
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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 ACIDR57ZHV85D4SHAMPOO / TOPICAL2 %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 ACIDR57ZHV85D4SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.3 %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 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 ACIDR57ZHV85D4GEL / OPHTHALMIC0.5 %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 ACIDR57ZHV85D4SOLUTION / AURICULAR (OTIC)0.05 %w/wExact 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 ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii candidate
17 equally ranked IID candidates
SODIUM NITRATESODIUM NITRATE8M4L3H2ZVZSOLUTION / OPHTHALMIC1.18 %w/wExact identifier — unii candidate
BORIC ACIDBORIC ACIDR57ZHV85D4DROPS / OPHTHALMIC1 %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 ACIDR57ZHV85D4INJECTION, SOLUTION / INTRAVENOUS210 mgExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SUSPENSION/ DROPS / OPHTHALMIC22 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 ACIDR57ZHV85D4JELLY / VAGINAL1 %w/wExact 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
1d5842a2-36bb-4279-ace9-ff3e19dc022b5475b6ea-7df2-446c-8df1-75879f389a892011-01-20WarningsExact identifier
spl id: 1d5842a2-36bb-4279-ace9-ff3e19dc022b
spl set id: 5475b6ea-7df2-446c-8df1-75879f389a89

Reported adverse events (FAERS/openFDA)#

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