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- polyethylene glycol 400, propylene glycol 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

Polyethylene Glycol 400 0.4%

Propylene Glycol 0.3%

PURPOSE

Lubricant

Uses

For the temporary relief of burning and irritation due to dryness of the eye.

Warnings

For external use only.

Do not use
if this product changes color or becomes cloudy
if you are sensitive to any ingredient in this product

When using this product
Do not touch tip of container to any surface to avoid contamination
Replace cap after each use

Stop use and ask a doctor if
You feel eye pain
Changes in vision occur
Redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours

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

Store at 20° to 25°C (68° to 77°F)  [see USP Controlled Room Temperature].

Inactive ingredients

Purified Water, Boric Acid, Hypromellose, Sodium Chloride, Potassium Chloride, Zinc Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH; Preservative, Benzalkonium Chloride.

Questions?

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

Long lasting

Soothing dry eye therapy

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 
polyethylene glycol 400, propylene glycol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73921-005
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	4 mg  in 1 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BORIC ACID (UNII: R57ZHV85D4)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73921-005-15	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(73921-005)

Revised: 2/2023

Document Id: f42b6382-0571-0e63-e053-2a95a90a211c

34390-5

Set id: 16f9c75f-25d6-4374-a1ad-c8759beee365

Version: 2

Effective Time: 20230208