FDA.reportPublic FDA data

Equate Eye Drops

Manufacturer
Prestige Brands Holdings, Inc.
Effective date
2024-10-25
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:36:42

Label at a glance#

ProductEquate Eye Drops
Active ingredientTETRAHYDROZOLINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

relieves redness of the eye due to minor eye irritations

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tetrahydrozoline Hydrochloride 0.05%

Purpose

OTC - PURPOSE SECTION

Redness reliever

Uses

INDICATIONS & USAGE SECTION

  • relieves redness of the eye due to minor eye irritations

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • if solution changes color or becomes cloudy

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • narrow angle glaucoma

When using this product

OTC - WHEN USING SECTION

  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using
  • overuse may produce increased redness of the eye
  • pupils may become enlarged temporarily

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you experience eye pain
  • you experience changes in vision
  • you experience continued redness or irritation of the eye
  • the condition worsens or persists for more than 72 hours

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 four times daily

Other information

OTHER SAFETY INFORMATION

  • store at room temperature
  • remove contact lenses before using

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1-888-287-1915

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Equate®
Original Redness Reliever
Tetrahydrozoline HCI
Sterile Eye Drops
1 FL OZ (30 mL)

Equate® Original Redness Reliever Tetrahydrozoline HCI Sterile Eye Drops 1 FL OZ (30 mL)Equate® Original Redness Reliever Tetrahydrozoline HCI Sterile Eye Drops 1 FL OZ (30 mL)

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Equate®
Original Redness
Reliever
Tetrahydrozoline HCI
Sterile Eye Drops
0.5 FL OZ (15 mL)

Equate® Original Redness Reliever Tetrahydrozoline HCI Sterile Eye Drops 0.5 FL OZ (15 mL)Equate® Original Redness Reliever Tetrahydrozoline HCI Sterile Eye Drops 0.5 FL OZ (15 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1052943tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSN7
1052943tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCD7
1052943tetrahydrozoline hydrochloride 0.05 % Eye DropsSY7
1052943tetrahydrozoline hydrochloride 0.05 % Ophthalmic SolutionSY7

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
67172-281-01Equate Eye Drops30 mL in 1 BOTTLE, DROPPERLIQUID307
67172-281-01Equate Eye Drops1 in 1 BOXLIQUID17
67172-282-01Equate Eye Drops1 in 1 BOXLIQUID17
67172-282-01Equate Eye Drops15 mL in 1 BOTTLE, DROPPERLIQUID157

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67172-281EQUATE EYE DROPS (TETRAHYROZOLINE HYDROCHLORIDE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]7Legacy NDC, 2 package rows20241113_7535168e-907b-4c34-9949-2d1ca6bfe08e.zip
67172-282EQUATE EYE DROPS (TETRAHYROZOLINE HYDROCHLORIDE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]7Legacy NDC, 2 package rows20241113_7535168e-907b-4c34-9949-2d1ca6bfe08e.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
67172-28267172-282-01
67172-28167172-281-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
TETRAHYDROZOLINE HYDROCHLORIDE0YZT43HS7DACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BORIC ACIDR57ZHV85D4IACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
SODIUM BORATE91MBZ8H3QOIACT
TETRAHYDROZOLINE HYDROCHLORIDE0YZT43HS7DACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BORIC ACIDR57ZHV85D4IACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
SODIUM BORATE91MBZ8H3QOIACT

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
67cde48d-49f7-4300-bacc-5d0d0801ccab7535168e-907b-4c34-9949-2d1ca6bfe08e2024-10-25WarningsExact identifier
spl id: 67cde48d-49f7-4300-bacc-5d0d0801ccab
spl set id: 7535168e-907b-4c34-9949-2d1ca6bfe08e

Reported adverse events (FAERS/openFDA)#

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