FDA.reportPublic FDA data

Kids Irritated Eye Relief

Manufacturer
Similasan Corporation
Effective date
2013-07-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 01:32:47

Label at a glance#

ProductKids Irritated Eye Relief
Active ingredientATROPA BELLADONNA, EUPHRASIA STRICTA, CALCIUM SULFIDE, PLATYCLADUS ORIENTALIS LEAF
Label structure15 sections

Indications and uses

According to homeopathic principles, the active ingredients in this medication temporarily relieve minor symptoms of eye irritations in children such as: redness of the eyes irritation, dryness, and burning sensation of grittiness excessive watering (clear) 

Dosage and administration

For children ages 2 and over: remove tamper-evident seal from neck of bottle twist cap off bottle squeeze plastic tip to release 1-2 drops into eye apply as needed replace cap after use 

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

dryness, redness, burning

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Euphrasia 6X 

Purpose

OTC - PURPOSE SECTION

redness, burning, watering 

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hepar sulphuris 12X 

Purpose

OTC - PURPOSE SECTION

sensation of grittiness, stinging 

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Thuja 15X 

Purpose

OTC - PURPOSE SECTION

eye irritation in children 

Uses:

INDICATIONS & USAGE SECTION

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

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

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.
  • 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.
  • Replace cap tightly after every use.
  • Contact wearers: consult physician prior to using. 

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
  • the child experiences eye pain
  • the child experiences continued redness or irritation of the eye
  • symptoms worsen or persist for more than 72 hours 

Directions:

DOSAGE & ADMINISTRATION SECTION

For children ages 2 and over:

  • remove tamper-evident seal from neck of bottle
  • twist cap off bottle
  • squeeze plastic tip to release 1-2 drops into eye
  • apply as needed
  • replace cap after use 

Other information:

SPL UNCLASSIFIED SECTION

Active ingredients are manufactured according to homeopathic principles. 

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 59262-362-11
Similasan
Kids Irritated Eye Relief
10 ml / 0.33 fl oz

NDC 59262-362-11 Similasan Kids Irritated Eye Relief 10 ml / 0.33 fl ozNDC 59262-362-11 Similasan Kids Irritated Eye Relief 10 ml / 0.33 fl oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59262-362-112023-03-03C16284748780-19d75b9cf-d76c-f424-e053-dadaa90a57ceKids Irritated Eye Relief
59262-362-112020-01-31C16284748780-19d75b9cf-d76c-f424-e053-dadaa90a57ceKids Irritated Eye Relief

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59262-362-11ML - Milliliter59262-362a8dd631e-7370-4538-9f21-6fa3634c985112022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H4
CALCIUM SULFIDEACTIVE INGREDIENT1MBW07J51Q4
EUPHRASIA STRICTAACTIVE INGREDIENTC9642I91WL4
PLATYCLADUS ORIENTALIS LEAFACTIVE INGREDIENT32E5V7G32B4
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H4
CALCIUM SULFIDEACTIVE MOIETY1MBW07J51Q4
EUPHRASIA STRICTAACTIVE MOIETYC9642I91WL4
PLATYCLADUS ORIENTALIS LEAFACTIVE MOIETY32E5V7G32B4
SILVER SULFATEINACTIVE INGREDIENT8QG6HV4ZPO4
SODIUM NITRATEINACTIVE INGREDIENT8M4L3H2ZVZ4
WATERINACTIVE INGREDIENT059QF0KO0R4

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
59262-36259262-362-11

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
CALCIUM SULFIDE1MBW07J51QACTIB
PLATYCLADUS ORIENTALIS LEAF32E5V7G32BACTIB
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 · 1 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
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
28bdeae2-364c-4f1c-9e69-5b18f10126e74e4b3d02-df14-4416-bf7c-880dd70d365c2023-03-02WarningsExact identifier
spl set id: 4e4b3d02-df14-4416-bf7c-880dd70d365c

Reported adverse events (FAERS/openFDA)#

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