FDA.reportPublic FDA data

Childrens Allergy Eye Relief

Manufacturer
Similasan Corporation
Effective date
2018-11-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:11:01

Label at a glance#

ProductChildrens Allergy Eye Relief
Active ingredientAPIS MELLIFERA, EUPHRASIA STRICTA, ANEMONE PATENS, SCHOENOCAULON OFFICINALE SEED
Label structure10 sections

Indications and uses

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

Dosage and administration

For 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 – Children’s Allergy Eye Relief

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Apis 6X      

Euphrasia officinalis (Eyebright) 6X

Pulsatilla 6X

Sabadilla 6X

Purpose

OTC - PURPOSE SECTION

burning, itching, swelling

redness, swelling, watering

itching, hay fever, watering, eye complaints in children

watering, redness of lids

Uses*

INDICATIONS & USAGE SECTION

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

• itching      

• burning

• redness of eyes and lids

• excessive watering

Warnings

WARNINGS SECTION

• For external use only.

• Children under 2 years of age should be seen by a physician.

• According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).

• To avoid contamination do not touch the tip of the bottle to any surface.

• To avoid contamination use within 30 days of opening. Expiration date only refers to unopened bottle.

• Contact wearers: consult a physician prior to using.

If pregnant, trying to get 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

• the child experiences eye pain or changes in vision

• symptoms worsen or persist for more than 72 hours

Directions

DOSAGE & ADMINISTRATION SECTION

For 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 59262-370-11
Similasan
Children’s
Allergy
Eye Relief
STERILE EYE DROPS
10 ml / 0.33 fl oz

NDC 59262-370-11 Similasan Children’s Allergy Eye Relief STERILE EYE DROPS 10 ml / 0.33 fl ozNDC 59262-370-11 Similasan Children’s Allergy Eye Relief STERILE EYE DROPS 10 ml / 0.33 fl oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59262-370-112021-01-29C16284748780-1ba0f9c33-0ecb-a910-e053-dadaa90a0b85Childrens Allergy Eye Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59262-370-11Childrens Allergy Eye Relief1 in 1 CARTONSOLUTION/ DROPS11
59262-370-11Childrens Allergy Eye Relief10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59262-370CHILDRENS ALLERGY EYE RELIEF (ANEMONE PATENS, APIS MELLIFERA, EUPHRASIA STRICTA AND SCHOENOCAULON OFFICINALE SEED) SOLUTION/ DROPS [SIMILASAN CORPORATION]1Legacy NDC, 2 package rows20190301_ef0711bc-4fcd-46e0-8c15-3ed58b75323a.zip

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
59262-37059262-370-11

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
APIS MELLIFERA7S82P3R43ZACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
ANEMONE PATENS4M1169RWJDACTIB
SCHOENOCAULON OFFICINALE SEED6NAF1689IOACTIB
WATER059QF0KO0RIACT
SILVER SULFATE8QG6HV4ZPOIACT
SODIUM NITRATE8M4L3H2ZVZIACT

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
5aedafd0-3285-467f-b0fd-6fa0e6a2f6e2ef0711bc-4fcd-46e0-8c15-3ed58b75323a2018-11-30WarningsExact identifier
spl id: 5aedafd0-3285-467f-b0fd-6fa0e6a2f6e2
spl set id: ef0711bc-4fcd-46e0-8c15-3ed58b75323a

Reported adverse events (FAERS/openFDA)#

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