i-Drops ARTIFICIAL TEARS

Manufacturer
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED
Effective date
2021-03-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:48:13

Label at a glance#

Producti-Drops ARTIFICIAL TEARS
Active ingredientPOLYVINYL ALCOHOL, UNSPECIFIED
Label structure10 sections

Indications and uses

For use as a lubricant to prevent further irritation or to relieve dryness of the eye(s).

Dosage and administration

Instill 1 or 2 drops in the affected eye(s) as needed.

Storage and handling

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store away from heat. Protect from freezing. Keep tightly closed. RETAIN THIS CARTON FOR FUTURE REFERENCE.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Polyvinyl Alcohol 1.4%

PURPOSE

OTC - PURPOSE SECTION

Eye lubricant

Uses

INDICATIONS & USAGE SECTION

For use as a lubricant to prevent further irritation or to relieve dryness of the eye(s).

Warnings

WARNINGS SECTION

• Do not use if seal on the bottle neck is broken or missing.

• Do not use if solution changes color or becomes cloudy.

• To avoid contamination, do not touch tip of container to any surface.

• Replace cap after using.

Stop use and ask a doctor if you experience
• Eye pain, • Changes in vision,
• Continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center.

Directions

DOSAGE & ADMINISTRATION SECTION

Instill 1 or 2 drops in the affected eye(s) as needed.

Other information

STORAGE AND HANDLING SECTION

Store at 20° to 25°C (68° to 77°F)

[see USP Controlled Room Temperature].

Store away from heat.

Protect from freezing.

Keep tightly closed. RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.005%, Edetate Disodium, Sodium Chloride, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Purified water, Sodium Hydroxide and/or Hydrochloric Acid to adjust pH.

Questions?

OTC - QUESTIONS SECTION

Call toll-free 1-800-572-6632, weekdays, 7:00 AM - 5:30 PM EST.

SPL UNCLASSIFIED SECTION

Lubricant Eye Drops

Prevents Irritation and Relieves Dryness of the Eye

Manufactured by:

Global Pharma Healthcare Pvt. Ltd., 

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Eye01Eye01

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73921-001-152023-02-08C16284748780-1f386c649-aa75-0266-e053-dadaa90a7c1ai-Drops ARTIFICIAL TEARS
73921-001-152023-01-30C16284748780-1f386c649-aa75-0266-e053-dadaa90a7c1ai-Drops ARTIFICIAL TEARS

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73921-00173921-001-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
f42dd661-a5bd-7266-e053-2a95a90ac53bc9892a97-5cf5-4088-8520-29c6e149cedc2023-02-08WarningsExact identifier
spl set id: c9892a97-5cf5-4088-8520-29c6e149cedc

Reported adverse events (FAERS/openFDA)#

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