FDA.reportPublic FDA data

Optimis7

Manufacturer
Pacific Health Collaborative, Inc.
Effective date
2016-03-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:21

Label at a glance#

ProductOptimis7
Active ingredientTETRAHYDROZOLINE HYDROCHLORIDE, DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE
Label structure8 sections

Dosage and administration

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

Storage and handling

store between 15° to 25°C (59°F to 77°F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Dextran 70 0.1%

Polyethylene Glycol 400 1%

Povidone 1%

Tetrahydrozoline HCl 0.5%

Purpose

OTC - PURPOSE SECTION

Lubricant

Lubricant

Lubricant

Redness reliever

Use

INDICATIONS & USAGE SECTION

  • for the relief of redness of the eye due to minor eye irritations
  • for use as a protectant against further irritation or to relieve dryness of the eye

Warnings

WARNINGS SECTION

Ask a doctor before use 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 use if this solution changes color or become cloudy
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Put 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

STORAGE AND HANDLING SECTION

  • store between 15° to 25°C (59°F to 77°F)


Inactive ingredients

INACTIVE INGREDIENT SECTION

boric acid, sodium borate, edetate disodium, benzalkonium chloride, sodium chloride, dilite hydrochloric acid, sterile purified water

package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Optimis7

optimis7optimis7

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 SolutionPSN1
1741538Optimis7 (0.1 % / 1 % / 1 % / 0.05 % ) Ophthalmic SolutionPSN1
1741538dextran 70 1 MG/ML / polyethylene glycol 400 10 MG/ML / povidone 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic Solution [Optimis7]SBD1
996202dextran 70 1 MG/ML / polyethylene glycol 400 10 MG/ML / povidone 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCD1
996202dextran 70 0.1 % / polyethylene glycol 400 1 % / povidone 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic SolutionSY1
1741538Optimis7 (dextran 70 0.1 % / polyethylene glycol 400 1 % / povidone 1 % / tetrahydrozoline HCl 0.05 % ) Ophthalmic SolutionSY1

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58697-064-052020-01-31C16284748780-19d75b9d0-31ea-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58697-064-05Optimis71 in 1 BOXLIQUID11
58697-064-05Optimis715 mL in 1 BOTTLELIQUID151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58697-064OPTIMIS7 (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [PACIFIC HEALTH COLLABORATIVE, INC.]1Legacy NDC, 2 package rows20160308_2d80ae24-1f9b-43d2-e054-00144ff88e88.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
58697-06458697-064-05

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
BORIC ACIDR57ZHV85D4IACT
SODIUM BORATE91MBZ8H3QOIACT
EDETATE DISODIUM7FLD91C86KIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT
TETRAHYDROZOLINE HYDROCHLORIDE0YZT43HS7DACTIB
DEXTRAN 707SA290YK68ACTIB
POLYETHYLENE GLYCOL 400B697894SGQACTIB
POVIDONEFZ989GH94EACTIB

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
2d80ae24-1f9c-43d2-e054-00144ff88e882d80ae24-1f9b-43d2-e054-00144ff88e882016-03-07WarningsExact identifier
spl id: 2d80ae24-1f9c-43d2-e054-00144ff88e88
spl set id: 2d80ae24-1f9b-43d2-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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