Irritated Eye Relief

Manufacturer
Similasan Corporation
Effective date
2019-03-20
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:11:08

Label at a glance#

ProductIrritated Eye Relief
Active ingredientATROPA BELLADONNA, EUPHRASIA STRICTA, CALCIUM SULFIDE
Label structure14 sections

Indications and uses

According to homeopathic principles, the active ingredients in this medication help relieve: redness of the eyes excessive watery (clear) discharge sensation of grittiness irritation, dryness, and burning

Dosage and administration

For adults: 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, burning, sensation of grittiness

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Euphrasia 6X

Purpose

OTC - PURPOSE SECTION

watery discharge

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hepar sulphuris 12X

Purpose

OTC - PURPOSE SECTION

redness, stinging

Uses:

INDICATIONS & USAGE SECTION

According to homeopathic principles, the active ingredients in this medication help relieve:

  • redness of the eyes
  • excessive watery (clear) discharge
  • sensation of grittiness
  • irritation, dryness, and burning

Warnings:

WARNINGS SECTION

  • For external use only.
  • Children under 2 years of age should be seen by a physician.
  • 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.

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 you are experiencing a think, white, yellow, or green discharge that forms a crust on the eyelid
  • if the solution changes color or becomes cloudy
  • if you experience eye pain or changes in vision
  • if you frequently contract infections that do not clear up easily

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 might have a serious underlying medical cause for the infection

Directions:

DOSAGE & ADMINISTRATION SECTION

For adults:

  • 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

Prinicipal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HOMEOPATHIC
NDC 59262-356-13
Similasan
Irritated
Eye Relief
sterile eye droppers
0.45 ml / 0.015 fl oz each
(0.9 ml / 0.03 fl oz total)

HOMEOPATHIC NDC 59262-356-13 Similasan Irritated Eye Relief sterile eye droppers 0.45 ml / 0.015 fl oz each (0.9 ml / 0.03 fl oz total)HOMEOPATHIC NDC 59262-356-13 Similasan Irritated Eye Relief sterile eye droppers 0.45 ml / 0.015 fl oz each (0.9 ml / 0.03 fl oz total)

Prinicipal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SIMILASAN / USA
30033
Irritated Eye Relief, eye drops,
Single-Use Droppers
2 x 0.45 ml, Trial size buffered
200 pieces (Stk.)
Batch
000000
Exp.
00/0000

SIMILASAN / USA 30033 Irritated Eye Relief, eye drops, Single-Use Droppers 2 x 0.45 ml, Trial size buffered 200 pieces (Stk.) Batch 000000 Exp. 00/0000SIMILASAN / USA 30033 Irritated Eye Relief, eye drops, Single-Use Droppers 2 x 0.45 ml, Trial size buffered 200 pieces (Stk.) Batch 000000 Exp. 00/0000

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59262-356-012021-01-29C16284748780-1ba0f9c33-1bd4-a910-e053-dadaa90a0b85Similasan Irritated Eye Relief
59262-356-132021-01-29C16284748780-1ba0f9c33-1bd4-a910-e053-dadaa90a0b85Similasan Irritated Eye Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59262-356-01Irritated Eye Relief200 in 1 CARTONSOLUTION/ DROPS2006
59262-356-01Irritated Eye Relief0.45 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS0.456
59262-356-13Irritated Eye Relief0.45 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS0.456

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59262-356IRRITATED EYE RELIEF (ATROPA BELLADONNA, EUPHRASIA STRICTA AND CALCIUM SULFIDE) SOLUTION/ DROPS [SIMILASAN CORPORATION]6Legacy NDC, 3 package rows20190321_fc56460f-2300-43c7-a4e2-a625e0245069.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H4
CALCIUM SULFIDEACTIVE INGREDIENT1MBW07J51Q4
EUPHRASIA STRICTAACTIVE INGREDIENTC9642I91WL4
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H4
CALCIUM SULFIDEACTIVE MOIETY1MBW07J51Q4
EUPHRASIA STRICTAACTIVE MOIETYC9642I91WL4
WATERINACTIVE INGREDIENT059QF0KO0R4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59262-35659262-356-01, 59262-356-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
2fc11990-a308-4457-a7b5-fcfff788a33dfc56460f-2300-43c7-a4e2-a625e02450692019-03-20WarningsExact identifier
spl id: 2fc11990-a308-4457-a7b5-fcfff788a33d
spl set id: fc56460f-2300-43c7-a4e2-a625e0245069

Reported adverse events (FAERS/openFDA)#

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