FDA.reportPublic FDA data

Kids Allergy Eye Relief

Manufacturer
Similasan AG
Effective date
2020-10-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:19:18

Label at a glance#

ProductKids Allergy Eye Relief
Active ingredientAPIS MELLIFERA, EUPHRASIA STRICTA, PULSATILLA VULGARIS, SCHOENOCAULON OFFICINALE SEED
Label structure15 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 1-2 drops into eye apply as needed replace cap after use

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Apis 6X

Purpose

OTC - PURPOSE SECTION

burning, itching, swelling

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Euphrasia officinalis (Eyebright) 6X

Purpose

OTC - PURPOSE SECTION

redness, swelling, watering

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Pulsatilla 6X

Purpose

OTC - PURPOSE SECTION

itching, hay fever, watering, eye complaints in children

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sabadilla 6X

Purpose

OTC - PURPOSE SECTION

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 1-2 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 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


Similasan
Kids Allergy Eye Relief
STERILE EYE DROPS
10 ml / 0.33 fl oz

Similasan Kids Allergy Eye Relief STERILE EYE DROPS 10 ml / 0.33 fl ozSimilasan Kids Allergy Eye Relief STERILE EYE DROPS 10 ml / 0.33 fl oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53799-500-112025-01-30C16284748780-12cef2736-9c74-d83d-e063-dadaa90ab31fKids Allergy Eye Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53799-500-11Kids Allergy Eye Relief10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS103
53799-500-11Kids Allergy Eye Relief1 in 1 BOXSOLUTION/ DROPS13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53799-500KIDS ALLERGY EYE RELIEF (APIS AND EUPHRASIA AND PULSATILLA AND SABADILLA) SOLUTION/ DROPS [SIMILASAN AG]3Legacy NDC, 2 package rows20230106_8a34c5d8-bda9-4fc1-967d-1117d9ecf80b.zip

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
53799-50053799-500-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
APIS MELLIFERA7S82P3R43ZACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
SCHOENOCAULON OFFICINALE SEED6NAF1689IOACTIB
BORIC ACIDR57ZHV85D4IACT
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
1f82aafc-a51d-43f3-b456-a2e022c75fa28a34c5d8-bda9-4fc1-967d-1117d9ecf80b2020-10-07WarningsExact identifier
spl id: 1f82aafc-a51d-43f3-b456-a2e022c75fa2
spl set id: 8a34c5d8-bda9-4fc1-967d-1117d9ecf80b

Reported adverse events (FAERS/openFDA)#

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