FDA.reportPublic FDA data

Womens Tear Stimulation

Manufacturer
Natural Ophthalmics, Inc
Effective date
2022-07-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:17:42

Label at a glance#

ProductWomens Tear Stimulation
Active ingredientPULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, EUPHRASIA STRICTA, ALUMINUM OXIDE, ARSENIC TRIOXIDE, NUTMEG, ZINC
Label structure13 sections

Indications and uses

According to homeopathic principles these drops are indicated for Women with acute or chronic dry eyes, often associated with hormone imbalance, Sjogren's or excessive watering secondary to dry eye.

Dosage and administration

Instill 1-3 drops in the eye. Use several times per day as needed.

Storage and handling

Safe Storage Room temperature 59 o to 86 o (15 o to 30 o C)

Label contents#

Full prescribing information#

Homeopathic Purpose

OTC - PURPOSE SECTION

  • Pulsatilla 8x }
  • Sepia 8x }
  • Euphrasia (Eyebright) 5x }
  • Alumina 10x } Dry eyes
  • Arsenicum album 12x }
  • Nux mosch 6x }
  • Zincum met 10x }

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Pulsatilla 8x
Sepia 8x
Euphrasia 5x
Alumina 10x
Arsenicum album 12x
Nux mosch 6x
Zincum m 11x

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified water
Polysorbate 80
Sodium citrate
Sodium chloride

Uses

INDICATIONS & USAGE SECTION

According to homeopathic principles these drops are indicated for Women with acute or chronic dry eyes, often associated with hormone imbalance, Sjogren's or excessive watering secondary to dry eye.

Directions

DOSAGE & ADMINISTRATION SECTION

Instill 1-3 drops in the eye. Use several times per day as needed.

Warnings

WARNINGS SECTION

For ophthalmic use.

For Professional Use Only

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. Incase of accidental ingestion, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if: You experience eye pain, changes in vision, continued redness or irritation of the eye. The condition worsens. Symptoms last longer than 72 hours.

Do not use

OTC - DO NOT USE SECTION

Do not use if solution becomes cloudy.

If pregnant or breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, ask a health professional before use.

Storage

STORAGE AND HANDLING SECTION

  • Safe Storage

Room temperature
59 o to 86 o (15 o to 30 o C)

OTC - QUESTIONS SECTION

Natural Ophthalmics, Inc.
Lafayette, CO 80026 USA
www.natoph.com
877-220-9710

Label image

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


CartonCarton

LabelLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68770-113-102024-01-30C16284748780-1d6a99b39-9100-a426-e053-dadaa90af4c2Women's Tear Stimulation
68770-113-102022-07-07C16284748780-1d6a99b39-9100-a426-e053-dadaa90af4c2Women's Tear Stimulation
68770-113-102022-01-28C16284748780-1d6a99b39-9100-a426-e053-dadaa90af4c2Women's Tear Stimulation

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68770-113-10Womens Tear Stimulation1 in 1 PACKAGELIQUID12
68770-113-10Womens Tear Stimulation10 mL in 1 BOTTLE, DROPPERLIQUID102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68770-113WOMENS TEAR STIMULATION (PULSATILLA, SEPIA, EUPHRASIA, ALUMINA, ARSENICUM ALBUM, NUX MOSCH, ZINCUM M) LIQUID [NATURAL OPHTHALMICS, INC]2Legacy NDC, 2 package rows20220709_aa6e0444-e241-629b-e053-2a95a90abcf1.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68770-11368770-113-10

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
WATER059QF0KO0RIACT
POLYSORBATE 806OZP39ZG8HIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM CHLORIDE451W47IQ8XIACT
PULSATILLA VULGARISI76KB35JEVACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
ALUMINUM OXIDELMI26O6933ACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
NUTMEGAEE24M3MQ9ACTIB
ZINCJ41CSQ7QDSACTIB

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
e33ced8c-f041-0e33-e053-2995a90a7e71aa6e0444-e241-629b-e053-2a95a90abcf12022-07-07WarningsExact identifier
spl id: e33ced8c-f041-0e33-e053-2995a90a7e71
spl set id: aa6e0444-e241-629b-e053-2a95a90abcf1

Reported adverse events (FAERS/openFDA)#

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