FDA.reportPublic FDA data

Walgreens Stye Eye Drops

Manufacturer
Similasan AG
Effective date
2020-10-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:19:21

Label at a glance#

ProductWalgreens Stye Eye Relief
Active ingredientCONIUM MACULATUM FLOWERING TOP, GRAPHITE, SULFUR
Label structure10 sections

Indications and uses

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as: • redness • burning • eyelid redness • tearing

Dosage and administration

For adults and 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 2 to 3 drops into eye • apply 3-4 times per day • replace cap after use • if desired, use with a warm, moistened washcloth placed directly on eyelid

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Conium maculatum 6X

Graphites 12X

Sulphur 12X

Purpose

OTC - PURPOSE SECTION

redness

eyelid redness

tearing, burning

Uses*

INDICATIONS & USAGE SECTION

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

• redness • burning • eyelid redness • tearing

Warnings

WARNINGS SECTION

•The purpose of this product is to provide temporary relief of stye symptoms, and is not a cure for styes.

• For external use only.

• 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

• if condition is accompanied by fever

Stop use and ask a doctor if:

OTC - STOP USE SECTION

• you experience eye pain or changes in vision

• symptoms worsen or persist for more than 72 hours

• the stye enlarges

• the stye opens, draining discharge or pus into the eye

Directions

DOSAGE & ADMINISTRATION SECTION

For adults and 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 2 to 3 drops into eye

• apply 3-4 times per day

• replace cap after use

• if desired, use with a warm, moistened washcloth placed directly on eyelid

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

1-800-925-4733

++This product is not distributed by Similasan AG, owner of the registered trademark SIMILASAN®.

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

FOR YOUR PROTECTION DO NOT USE IF TAMPER EVIDENT SEAL AROUND NECK IS MISSING OR BROKEN

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Stye Eye

Drops
0.33 FL OZ (10 mL)

PRINCIPAL DISPLAY PANEL Stye Eye Drops 0.33 FL OZ (10 mL)PRINCIPAL DISPLAY PANEL Stye Eye Drops 0.33 FL OZ (10 mL)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53799-404-112025-01-30C16284748780-12cef2736-8a37-d83d-e063-dadaa90ab31fWalgreens Stye Eye Drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53799-404-11Walgreens Stye Eye Relief1 in 1 CARTONSOLUTION/ DROPS12
53799-404-11Walgreens Stye Eye Relief10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53799-404WALGREENS STYE EYE RELIEF (GRAPHITE, SULFUR, CONIUM MACULATUM) SOLUTION/ DROPS [SIMILASAN AG]2Legacy NDC, 2 package rows20230106_f777aefd-01ad-4f27-a55f-77acc6180589.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53799-40453799-404-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CONIUM MACULATUM FLOWERING TOPQ28R5GF371ACTIB
GRAPHITE4QQN74LH4OACTIB
SULFUR70FD1KFU70ACTIB
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
72c052b6-a99c-462e-bdf3-73cdc6b0c44ff777aefd-01ad-4f27-a55f-77acc61805892020-10-07WarningsExact identifier
spl id: 72c052b6-a99c-462e-bdf3-73cdc6b0c44f
spl set id: f777aefd-01ad-4f27-a55f-77acc6180589

Reported adverse events (FAERS/openFDA)#

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