Dry Eye Relief

Manufacturer
Similasan Corporation | International Packaging Inc
Effective date
2018-11-14
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:11:12

Label at a glance#

ProductDry Eye Relief
Active ingredientATROPA BELLADONNA, EUPHRASIA STRICTA, MERCURIC CHLORIDE
Label structure12 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 a single-use dropper twist flat end with ball to remove squeeze plastic dropper to release 2-3 drops into eye and discard applicator

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.
  • Use only if single-use dropper is intact.
  • To avoid contamination, do not touch the tip of the dropper to any surface. Do not reuse. Once opened, discard.
  • Contact wearers: consult a physician prior to using.

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.

If pregnant or breast feeding,

PREGNANCY 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.

Directions

DOSAGE & ADMINISTRATION SECTION

For adults and children age 2 and over:

  • remove a single-use dropper
  • twist flat end with ball to remove
  • squeeze plastic dropper to release 2-3 drops into eye and discard applicator

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Phosphate buffer, Purified water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 59262-352-13
Similasan
Dry Eye
Relief
SINGLE-USE STERILE EYE DROPS
Preservative Free
0.4 ml/ 0.014 fl oz each
NDC 59262-352-13 Similasan Dry Eye Relief SINGLE-USE STERILE EYE DROPS Preservative Free 0.4 ml/ 0.014 fl oz eachNDC 59262-352-13 Similasan Dry Eye Relief SINGLE-USE STERILE EYE DROPS Preservative Free 0.4 ml/ 0.014 fl oz each


Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SIMILASAN / USA
30011
Dry Eye Relief, eye drops
270 pieces(Stk)

SIMILASAN / USA 30011 Dry Eye Relief, eye drops 270 pieces(Stk)
SIMILASAN / USA 30011 Dry Eye Relief, eye drops 270 pieces(Stk)

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59262-352-012021-01-29C16284748780-1ba0f9c33-25f9-a910-e053-dadaa90a0b85Similasan Dry Eye Relief Trial Size
59262-352-132021-01-29C16284748780-1ba0f9c33-25f9-a910-e053-dadaa90a0b85Similasan Dry Eye Relief Trial Size

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59262-352-01Dry Eye Relief0.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.47
59262-352-01Dry Eye Relief270 in 1 CARTONSOLUTION/ DROPS2707
59262-352-13Dry Eye Relief.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS.47

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59262-352DRY EYE RELIEF (ATROPA BELLADONNA AND EUPHRASIA STRICTA AND MERCURIC CHLORIDE) SOLUTION/ DROPS [SIMILASAN CORPORATION]7Legacy NDC, 3 package rows20190329_556395b6-a928-44a0-929a-e7ffa2f5e358.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H6
EUPHRASIA STRICTAACTIVE INGREDIENTC9642I91WL6
MERCURIC CHLORIDEACTIVE INGREDIENT53GH7MZT1R6
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H6
EUPHRASIA STRICTAACTIVE MOIETYC9642I91WL6
MERCURIC CATIONACTIVE MOIETYED30FJ8Y426
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6F6
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEINACTIVE INGREDIENT5QWK6659566
WATERINACTIVE INGREDIENT059QF0KO0R6

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
59262-35259262-352-01, 59262-352-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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 2 · 61 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FTROCHE / ORAL28 mgExact identifier — unii candidate
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SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956INJECTION, SOLUTION / INTRAVENOUS115 mgExact identifier — unii candidate
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SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956INJECTION / INTRAMUSCULAR12.8 mgExact identifier — unii candidate
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SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SUSPENSION / INTRA-ARTICULAR36 mgExact identifier — unii candidate
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SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FTABLET, EXTENDED RELEASE / ORAL210 mgExact identifier — unii candidate
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SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINSERT / INTRAOCULAR0.02 mgExact identifier — unii candidate
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SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FOINTMENT / TOPICAL1 mgExact identifier — unii candidate
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SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956GEL / TOPICAL0.02 %w/wExact identifier — unii candidate
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SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSOLUTION/ DROPS / OPHTHALMIC1.4 %w/vExact identifier — unii candidate
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SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956INJECTION, SOLUTION / SUBCUTANEOUS0.3 %w/vExact identifier — unii candidate
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SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR139.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION / SUBCUTANEOUS20 mgExact identifier — unii candidate
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SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS139.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SUSPENSION / INTRAMUSCULAR36 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION / INTRALESIONAL28 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SUSPENSION / INTRALESIONAL3 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FCAPSULE, DELAYED RELEASE / ORAL43 mgExact identifier — unii candidate
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SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSOLUTION / INTRAVENOUS381 mgExact identifier — unii candidate
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SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FTABLET, FOR SUSPENSION / ORAL60 mgExact identifier — unii candidate
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SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FLIQUID / INTRAVENOUS381 mgExact identifier — unii candidate
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SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SOLUTION / INTRAVENOUS2460 mgExact identifier — unii candidate
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SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FCAPSULE, EXTENDED RELEASE / ORAL207 mgExact identifier — unii candidate
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SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION / INTRAMUSCULAR1751 mgExact identifier — unii candidate
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SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSOLUTION / NASAL5 mgExact identifier — unii candidate
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SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SOLUTION / INTRAVESICAL38.25 mgExact identifier — unii candidate
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SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FFILM / SUBLINGUAL6 mgExact identifier — unii candidate
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SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION / INTRAVENOUS381 mgExact identifier — unii candidate
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13 equally ranked IID candidates
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SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FTABLET / ORAL96 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS1.6 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956INJECTION / INTRAVENOUS12.8 mgExact identifier — unii candidate
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13 equally ranked IID candidates
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48 equally ranked IID candidates
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48 equally ranked IID candidates
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13 equally ranked IID candidates
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48 equally ranked IID candidates
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48 equally ranked IID candidates
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13 equally ranked IID candidates
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48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956SOLUTION / OPHTHALMIC2 mgExact identifier — unii candidate
13 equally ranked IID candidates
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13 equally ranked IID candidates
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48 equally ranked IID candidates
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48 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
1810cfc8-666f-42d2-8783-9768b3c19801556395b6-a928-44a0-929a-e7ffa2f5e3582018-11-14WarningsExact identifier
spl id: 1810cfc8-666f-42d2-8783-9768b3c19801
spl set id: 556395b6-a928-44a0-929a-e7ffa2f5e358

Reported adverse events (FAERS/openFDA)#

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