LuteSol Homeopathic Medicine Sterile Eye Drops

Manufacturer
Yokina Inc.
Effective date
2018-12-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:10:40

Label at a glance#

ProductLuteSol Homeopathic Medicine Sterile Eye Drops
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP
Label structure9 sections

Indications and uses

According to homeopathic indications these ingredients provide temporary relief from symptoms such as Dryness, redness and promote corneal health, after a serious causes have been ruled out by physician. *These statements are based on traditional homeopathic practice. They have not been reviewed by Food and Drug Administration

Storage and handling

• There are known contraindications • Active ingredients are micro-diluted in accordance with Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects. • Store at room temperature • Do not touch tip of container to any surface to avoid contamination • Keep bottle tightly closed

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Calendula Officinalis (Marigold containing Lutein), HPUS 3x, 6x, 12x

"HPUS" indicates the active ingredients of this product are officially monographed in the Homeopathic Pharmacopoeia of the United States

Purpose

OTC - PURPOSE SECTION

Corneal health

Uses*

INDICATIONS & USAGE SECTION

According to homeopathic indications these ingredients provide temporary relief from symptoms such as Dryness, redness and promote corneal health, after a serious causes have been ruled out by physician.

*These statements are based on traditional homeopathic practice. They have not been reviewed by Food and Drug Administration

Warnings

WARNINGS SECTION

For external use only.

• This product is intended to complement, not replace standard medical treatment • Suitable for adults and children ages 12 and over. • Initial worsening of symptoms may occur • If pregnant or breast-feeding, ask a health professional before use • Contact lens wearers: Consult a physician before use • Replace cap after every use • Expiration date only refers to the unopened bottle. • The use of this container to more than one person may spread infection

Do not use if : • Solution changes color or becomes cloudy • You feel eye pain or changes in vision, continued redness, or the irritation of the eye • The condition get worse • redness or irritation of the eye(s) get worse, persists or last longer than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• Keep out of reach of children • In case of accidental ingestion, get medical help or contact a poison control center right away

Direction:

DOSAGE & ADMINISTRATION SECTION

• Shake well before using

• Instill 1-3 drops in the affected eye(s). Use several times per day as needed.

• Homeopathic remedies may not be effective for everyone.

• Individual results may vary.

Other information:

STORAGE AND HANDLING SECTION

• There are known contraindications

• Active ingredients are micro-diluted in accordance with Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects.

• Store at room temperature

• Do not touch tip of container to any surface to avoid contamination

• Keep bottle tightly closed

Inactive ingredient:

INACTIVE INGREDIENT SECTION

Polyethylene Glycol, Propylene glycol, Benzalkonium chloride, Boric acid, Calcium chloride, Hydrochloric acid, Hypromellose, Magnesium chloride, Potassium chloride, Purified water, Sodium chloride, Sodium hydroxide, Zinc chloride

SPL UNCLASSIFIED SECTION

Supports:

Corneal Health

Healthy Vision

Dry Eyes

Made In USA

U.S. Distributor:

Yokina Inc.

Rancho cucamonga,

CA 91730

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lutesol-1Lutesol-1

DailyMed Product Concepts#

Product concept, Relation, Version table
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72709-821-782020-01-31C16284748780-19d75b9cf-f0bc-f424-e053-dadaa90a57ceLuteSol Homeopathic Medicine Sterile Eye Drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72709-821-78LuteSol Homeopathic Medicine Sterile Eye Drops1 in 1 BOXSOLUTION/ DROPS11
72709-821-78LuteSol Homeopathic Medicine Sterile Eye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72709-821LUTESOL HOMEOPATHIC MEDICINE STERILE EYE DROPS (CALENDULA OFFICINALIS) SOLUTION/ DROPS [ YOKINA INC. ]1Legacy NDC, 2 package rows20181228_ee90e4bf-38d5-43cb-9203-e659626724bc.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72709-82172709-821-78

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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
42cf329e-fa9f-44a6-948e-68bd116e4f7fee90e4bf-38d5-43cb-9203-e659626724bc2018-12-20WarningsExact identifier
spl id: 42cf329e-fa9f-44a6-948e-68bd116e4f7f
spl set id: ee90e4bf-38d5-43cb-9203-e659626724bc

Reported adverse events (FAERS/openFDA)#

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