i-Drops LUBRICANT EYE DROPS

i-Drops LUBRICANT EYE DROPS by

Drug Labeling and Warnings

i-Drops LUBRICANT EYE DROPS by is a Otc medication manufactured, distributed, or labeled by GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

I-DROPS LUBRICANT EYE DROPS- glycerin, hypromellose, polyethylene glycol 400 solution/ drops 
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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i-Drops LUBRICANT EYE DROPS

DRUG FACTS

ACTIVE INGREDIENT

Glycerin 0.2%
Hypromellose 0.2%
Polyethylene Glycol 400 1%

PURPOSE

Lubricant

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.

Warnings

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

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

Directions

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

Other information

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

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?

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

Lubricate    Soothes

Moisturizes

Manufactured by:

Global Pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

I-DROPS LUBRICANT EYE DROPS 
glycerin, hypromellose, polyethylene glycol 400 solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73921-007
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	2 mg  in 1 mL
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) (HYPROMELLOSE, UNSPECIFIED - UNII:3NXW29V3WO)	HYPROMELLOSE, UNSPECIFIED	2 mg  in 1 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCINE (UNII: TE7660XO1C)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM LACTATE (UNII: TU7HW0W0QT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73921-007-15	1 in 1 CARTON	04/01/2021	02/08/2023
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	04/01/2021	02/08/2023

Labeler - GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)

Establishment
Name	Address	ID/FEI	Business Operations
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED		860186917	manufacture(73921-007)

Revised: 2/2023

Document Id: f42b6ac8-c304-1273-e053-2995a90a0ddb

34390-5

Set id: da9c2564-722a-4691-bd36-9cd9013d7de2

Version: 2

Effective Time: 20230208