FDA.reportPublic FDA data

i-Drops LUBRICANT EYE DROPS

Manufacturer
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED
Effective date
2021-03-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:48:01

Label at a glance#

Producti-Drops LUBRICANT EYE DROPS
Active ingredientGLYCERIN, HYPROMELLOSE, UNSPECIFIED, POLYETHYLENE GLYCOL 400
Label structure10 sections

Indications and uses

• For use as a protectant against further irritation or to relieve dryness of the eye. • For the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun.

Dosage and administration

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

Storage and handling

Do not use if the tamper-resistant bottle cap is broken or opened. RETAIN THIS CARTON FOR FUTURE REFERENCE store between 15° to 30°C (59°F to 86°F).

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Glycerin 0.2%
Hypromellose 0.2%
Polyethylene Glycol 400 1%

PURPOSE

OTC - PURPOSE SECTION

Lubricant

Uses

INDICATIONS & USAGE SECTION

• For use as a protectant against further irritation or to relieve dryness of the eye.
• For the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun.

Warnings

WARNINGS SECTION

Do not use this product if solution changes color or becomes cloudy

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.

When using this product
To avoid contamination, do not touch tip of container to any surface.
Replace cap after using. Keep container tightly closed.
Remove contact lens before using

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

Do not use if the tamper-resistant bottle cap is broken or opened.

RETAIN THIS CARTON FOR FUTURE REFERENCE

store between 15° to 30°C (59°F to 86°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aminoacetic acid, Ascorbic acid, Benzalkonium chloride, Boric acid, Disodium phosphate, Magnesium chloride, Potassium chloride, Purified water, Sodium borate, Sodium chloride, Sodium citrate, Sodium lactate.

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

• Lubricate    • Soothes

• Moisturizes


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

idrops07-1idrops07-1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73921-007-152023-02-08C16284748780-1f386c64a-20cc-0266-e053-dadaa90a7c1ai-Drops LUBRICANT EYE DROPS
73921-007-152023-01-30C16284748780-1f386c64a-20cc-0266-e053-dadaa90a7c1ai-Drops LUBRICANT EYE DROPS

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73921-00773921-007-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXACTIB
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOACTIB
POLYETHYLENE GLYCOL 400B697894SGQACTIB
GLYCINETE7660XO1CIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BORIC ACIDR57ZHV85D4IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
POTASSIUM CHLORIDE660YQ98I10IACT
WATER059QF0KO0RIACT
SODIUM BORATE91MBZ8H3QOIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SODIUM LACTATETU7HW0W0QTIACT

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
f42b6ac8-c304-1273-e053-2995a90a0ddbda9c2564-722a-4691-bd36-9cd9013d7de22023-02-08WarningsExact identifier
spl set id: da9c2564-722a-4691-bd36-9cd9013d7de2

Reported adverse events (FAERS/openFDA)#

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