FDA.reportPublic FDA data

Equaline Advanced Relief Eye Drops

Manufacturer
United Natural Foods, Inc. | K.C. Pharmaceuticals, Inc. | KC Pharmaceuticals, Inc
Effective date
2023-12-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:05:37

Label at a glance#

ProductEqualine Advanced Relief Eye Drops
Active ingredientDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

relieves redness of the eye due to minor eye irritations as a lubricant to prevent further irritation or to relieve dryness of the eye

Dosage and administration

Instill 1 or 2 drops in the affected eye(s) up to four times daily

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Dextran 70 0.1%

Polyethylene glycol 400 1%

Povidone 1%

Tetrahydrozoline HCl 0.05%

Purposes

OTC - PURPOSE SECTION

Lubricant

Lubricant

Lubricant

Redness reliever

Uses

INDICATIONS & USAGE SECTION

  • relieves redness of the eye due to minor eye irritations
  • as a lubricant to prevent further irritation or to relieve dryness of the eye

Warnings

WARNINGS SECTION

For external use only

Ask a doctor before us if you have

OTC - ASK DOCTOR SECTION

narrow angle glaucoma

When using this product

OTC - WHEN USING SECTION

  • pupils may become enlarged temporarily
  • to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
  • if solution changes color or becomes cloudy,do not use
  • overuse may produce increased redness of the eye
  • remove contact lens before using

Stop use and ask a doctor if you experience

OTC - STOP USE SECTION

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye, or if the condition worsens or persists for 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 or 2 drops in the affected eye(s) up to four times daily

Other information

OTHER SAFETY INFORMATION

Store at 15 °-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride

Equaline Advanced Relief Eye Drops

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Equaline Advanced Relief Eye DropsEqualine Advanced Relief Eye Drops

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996202dextran 70 0.1 % / polyethylene glycol 400 1 % / povidone 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSN3
996202dextran 70 1 MG/ML / polyethylene glycol 400 10 MG/ML / povidone 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCD3
996202dextran 70 0.1 % / polyethylene glycol 400 1 % / povidone 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTRAN 70 Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
41163-338-01Equaline Advanced Relief Eye Drops1 in 1 BOXSOLUTION/ DROPS13
41163-338-01Equaline Advanced Relief Eye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-338EQUALINE ADVANCED RELIEF EYE DROPS (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [UNITED NATURAL FOODS, INC.]3Current NDC, 2 package rows20231224_f7602789-179a-edfc-e053-6294a90a0844.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41163-33841163-338-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BORIC ACIDR57ZHV85D4IACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
SODIUM BORATE91MBZ8H3QOIACT
SODIUM CHLORIDE451W47IQ8XIACT
DEXTRAN 707SA290YK68ACTIB
POLYETHYLENE GLYCOL 400B697894SGQACTIB
POVIDONEFZ989GH94EACTIB
TETRAHYDROZOLINE HYDROCHLORIDE0YZT43HS7DACTIB

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 Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEUnited Natural Foods, Inc.f7602789-179a-edfc-e053-6294a90a08442023-12-20WarningsExact identifier
ndc (package): 41163-338-01
ndc (product): 41163-338
ndc11 (package): 41163033801
spl id: 0cfa84bd-0fca-c574-e063-6394a90aa9b2
spl set id: f7602789-179a-edfc-e053-6294a90a0844

Reported adverse events (FAERS/openFDA)#

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