FDA.reportPublic FDA data

Equaline Multi-Symptom Eye Drops

Manufacturer
United Natural Foods, Inc. | KC Pharmaceuticals, Inc.
Effective date
2025-12-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:30:58

Label at a glance#

ProductEqualine Multi-Symptom Eye Drops
Active ingredientZINC SULFATE, POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

relieves dryness of the eye for temporary relief of discomfort and redness of the eye due to minor eye irritations for temporary relief of burning and irritation due to exposure to wind or sun for protection against further irritation

Dosage and administration

instill 1 to 2 drops in the affected eye(s) up to 4 times daily children under 6 years of age: ask a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Polyethylene glycol 400 1%

Tetrahydrozoline HCl 0.05%

Zinc sulfate 0.25%

Purposes

OTC - PURPOSE SECTION

Lubricant

Redness reliever

Astringent

Uses

INDICATIONS & USAGE SECTION

  • relieves dryness of the eye
  • for temporary relief of discomfort and redness of the eye due to minor eye irritations
  • for temporary relief of burning and irritation due to exposure to wind or sun
  • for protection against further irritation

Warnings

WARNINGS SECTION

For external use only

Ask a doctor before use

OTC - ASK DOCTOR SECTION

if you have narrow angle glaucoma

When using this product

OTC - WHEN USING SECTION

  • pupils may become enlarged temporarily
  • overuse may cause more eye redness
  • remove contact lenses before using
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after using
  • do not use if this solution changes color or becomes cloudy

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye lasts
  • condition worsens or lasts more than 72 hours

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • instill 1 to 2 drops in the affected eye(s) up to 4 times daily
  • children under 6 years of age: ask a doctor

Other information

OTHER SAFETY INFORMATION

  • some users may experience a brief tingling sensation
  • store at 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, boric acid, edetate disodium, glycerin, hypromellose, purified water, sodium chloride, sodium citrate

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-855-423-2630

Equaline Multi-Symptom Eye Drops 15mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Equaline Multi-Symptom Eye Drops 15mLEqualine Multi-Symptom Eye Drops 15mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2360903polyethylene glycol 400 1 % / tetrahydrozoline hydrochloride 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionPSN3
2360903polyethylene glycol 400 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML / zinc sulfate 2.5 MG/ML Ophthalmic SolutionSCD3
2360903polyethylene glycol 400 1 % / tetrahydrozoline hydrochloride 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionSY3
2360903polyethylene glycol 400 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML / ZnSO4 2.5 MG/ML Ophthalmic SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130041163503861GTIN-13: 0041163503861
EAN-13: 0041163503861
GTIN-12: 041163503861
UPC-A: 041163503861
GTIN storage (14 digits): 00041163503861		Equaline Multi-Symptom Eye Drops 15mL.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83455-207-01Equaline Multi-Symptom Eye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS153
83455-207-01Equaline Multi-Symptom Eye Drops1 in 1 BOXSOLUTION/ DROPS13

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83455-20783455-207-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC SULFATE89DS0H96TBACTIB
GLYCERINPDC6A3C0OXIACT
SODIUM CHLORIDE451W47IQ8XIACT
EDETATE DISODIUM7FLD91C86KIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 400B697894SGQACTIB
TETRAHYDROZOLINE HYDROCHLORIDE0YZT43HS7DACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
SODIUM CITRATE1Q73Q2JULRIACT
BORIC ACIDR57ZHV85D4IACT

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
Equaline Multi-Symptom Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATEUnited Natural Foods, Inc.fe467606-6d66-b695-e053-6294a90aab5d2025-12-30WarningsExact identifier
ndc (package): 83455-207-01
ndc (product): 83455-207
ndc11 (package): 83455020701
spl id: 474a9e15-235b-5608-e063-6294a90a9632
spl set id: fe467606-6d66-b695-e053-6294a90aab5d

Reported adverse events (FAERS/openFDA)#

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