Irritated Eye Drops

Manufacturer
Walgreen Company
Effective date
2012-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:04:14

Label at a glance#

ProductIrritated Eye
Active ingredientATROPA BELLADONNA, EUPHRASIA STRICTA, CALCIUM SULFIDE
Label structure15 sections

Indications and uses

According to homeopathic principles, the active ingredients in this medication help relieve: redness of the eyes excessive watery (clear) discharge sensation of grittiness irritation, dryness, and burning

Dosage and administration

For adults and children ages 2 and over: remove tamper-evident seal from neck of bottle twist cap off bottle squeeze plastic tip to release 2-3 drops into eye apply as needed replace cap after use

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Belladonna 6X*

*containing 0.000002% alkaloids calculated as hyoscyamine

Purpose

OTC - PURPOSE SECTION

dryness, redness, burning, sensation of grittiness

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Euphrasia 6X

Purpose

OTC - PURPOSE SECTION

watery discharge

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hepar sulphuris 12X

Purpose

OTC - PURPOSE SECTION

redness, stinging

Uses:

INDICATIONS & USAGE SECTION

According to homeopathic principles, the active ingredients in this medication help relieve:

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

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.
  • The use of this container by more than one person may spread infection.

If 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 you are experiencing a think, white, yellow, or green discharge that forms a crust on the eyelid
  • if the solution changes color or becomes cloudy
  • if you experience eye pain or changes in vision
  • if you frequently contract infections that do not clear up easily

Stop use and ask a doctor if:

OTC - ASK DOCTOR SECTION

  • symptoms worsen or persist for more than 72 hours
  • changes in vision occur
  • you might have a serious underlying medical cause for the infection

Directions:

DOSAGE & ADMINISTRATION SECTION

For adults and children ages 2 and over:

  • remove tamper-evident seal from neck of bottle
  • twist cap off bottle
  • squeeze plastic tip to release 2-3 drops into eye
  • apply as needed
  • replace cap after use

Other Information:

INFORMATION FOR OWNERS/CAREGIVERS 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 or comments?

OTC - QUESTIONS SECTION

1-800-WALGREENS (1-800-925-4733)

Prinicipal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0363-9031-11
STERILE
HOMEOPATHIC
Irritated
Eye Drops
• Relieves redness, watery
discharge, burning,
grittiness,
dryness &
stinging
• Safe & effective
0.33 FL OZ (10 mL)

NDC 0363-9031-11 STERILE HOMEOPATHIC Irritated Eye Drops • Relieves redness, watery discharge, burning, grittiness, dryness & stinging • Safe & effective 0.33 FL OZ (10 mL)
NDC 0363-9031-11 STERILE HOMEOPATHIC Irritated Eye Drops • Relieves redness, watery discharge, burning, grittiness, dryness & stinging • Safe & effective 0.33 FL OZ (10 mL)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-9031-112020-01-31C16284748780-19d75b9cf-e44d-f424-e053-dadaa90a57ceIrritated Eye Drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9031-11Irritated Eye10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS102
0363-9031-11Irritated Eye1 in 1 CARTONSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9031IRRITATED EYE (ATROPA BELLADONNA AND CALCIUM SULFIDE AND EUPHRASIA STRICTA) SOLUTION/ DROPS [WALGREEN COMPANY]2Legacy NDC, 2 package rows20130110_382b5062-2fcb-4b30-b430-a020700813cb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-9031-11ML - Milliliter0363-9031178e9be6-9dc2-48e1-b13c-a305429a4ee912022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H2
CALCIUM SULFIDEACTIVE INGREDIENT1MBW07J51Q2
EUPHRASIA STRICTAACTIVE INGREDIENTC9642I91WL2
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H2
CALCIUM SULFIDEACTIVE MOIETY1MBW07J51Q2
EUPHRASIA STRICTAACTIVE MOIETYC9642I91WL2
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D42
SILVER SULFATEINACTIVE INGREDIENT8QG6HV4ZPO2
SODIUM NITRATEINACTIVE INGREDIENT8M4L3H2ZVZ2
WATERINACTIVE INGREDIENT059QF0KO0R2

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
0363-90310363-9031-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BORIC ACIDBORIC ACIDR57ZHV85D4SUSPENSION/ DROPS / AURICULAR (OTIC)3 mgExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4DROPS / OPHTHALMIC1 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SUSPENSION / AURICULAR (OTIC)0.6 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4EMULSION / TOPICAL1.3 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION / OPHTHALMIC60 mgExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4INJECTION, SOLUTION / INTRAVENOUS210 mgExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS0.53 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4EMULSION / OPHTHALMIC0.3 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4MOUTHWASH / BUCCAL7.36 mg/1mlExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SHAMPOO / TOPICAL2 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SUSPENSION/ DROPS / OPHTHALMIC22 mgExact identifier — unii candidate
17 equally ranked IID candidates
SODIUM NITRATESODIUM NITRATE8M4L3H2ZVZSOLUTION / OPHTHALMIC1.18 %w/wExact identifier — unii candidate
BORIC ACIDBORIC ACIDR57ZHV85D4JELLY / VAGINAL1 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SUSPENSION/ DROPS / TOPICAL0.3 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4GEL / OPHTHALMIC0.5 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.3 %w/wExact identifier — unii candidate
17 equally ranked IID candidates

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
7571e1f3-981a-4141-ba71-261f4bed6fa2382b5062-2fcb-4b30-b430-a020700813cb2012-12-20WarningsExact identifier
spl id: 7571e1f3-981a-4141-ba71-261f4bed6fa2
spl set id: 382b5062-2fcb-4b30-b430-a020700813cb

Reported adverse events (FAERS/openFDA)#

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