FDA.reportPublic FDA data

Kids Pink Eye Relief

Manufacturer
Similasan AG
Effective date
2020-10-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:19:19

Label at a glance#

ProductKids Pink Eye Relief
Active ingredientATROPA BELLADONNA, EUPHRASIA STRICTA, CALCIUM SULFIDE, PLATYCLADUS ORIENTALIS LEAF
Label structure10 sections

Indications and uses

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms 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 • 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

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Belladonna 6X†

Euphrasia officinalis (Eyebright) 6X

Hepar sulphuris 12X

Thuja 15X

Purpose

OTC - PURPOSE SECTION

dryness, redness, burning

redness, burning, watering

sensation of grittiness, stinging

irritation

Uses*

INDICATIONS & USAGE SECTION

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms 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.

• 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 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 ages 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

†containing 0.000002% alkaloids calculated as hyoscyamine

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


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

PRINCIPAL DISPLAY PANEL Similasan Kids Pink Eye Relief STERILE EYE DROPS 10 ml / 0.33 fl ozPRINCIPAL DISPLAY PANEL Similasan Kids Pink Eye Relief STERILE EYE DROPS 10 ml / 0.33 fl oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53799-368-112025-01-30C16284748780-12cef2736-76a7-d83d-e063-dadaa90ab31fKids Pink Eye Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53799-368-11Kids Pink Eye Relief10 mL in 1 BOTTLE, DROPPERLIQUID102
53799-368-11Kids Pink Eye Relief1 in 1 CARTONLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53799-368KIDS PINK EYE RELIEF (ATROPA BELLADONNA, CALCIUM SULFIDE, EUPHRASIA STRICTA AND PLATYCLADUS ORIENTALIS LEAF) LIQUID [SIMILASAN AG]2Legacy NDC, 2 package rows20230106_a838d38a-b4d2-4b59-ab67-74a3c8e38077.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
53799-36853799-368-11

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

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
2f17982f-cc1c-41b3-a821-b35c46e7c6efa838d38a-b4d2-4b59-ab67-74a3c8e380772020-10-07WarningsExact identifier
spl id: 2f17982f-cc1c-41b3-a821-b35c46e7c6ef
spl set id: a838d38a-b4d2-4b59-ab67-74a3c8e38077

Reported adverse events (FAERS/openFDA)#

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