i-Drops ARTIFICIAL TEARS by GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED i-Drops ARTIFICIAL TEARS

i-Drops ARTIFICIAL TEARS by

Drug Labeling and Warnings

i-Drops ARTIFICIAL TEARS 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 ARTIFICIAL TEARS- polyvinyl alcohol, povidone 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 ARTIFICIAL TEARS

DRUG FACTS

ACTIVE INGREDIENT

Polyvinyl alcohol 0.5%

Povidone 0.6%

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

For external use only.

Do not use this product if 

 Solution changes color or becomes cloudy

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

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

Keep out of the reach of children.
If accidentally 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 15°-30°C (59°-86°F)

Inactive ingredients

Benzalkonium chloride, Dextrose, Edetate disodium, Potassium chloride, Purified water, Sodium bicarbonate, Sodium chloride, Sodium citrate, Sodium phosphate dibasic, Sodium phosphate monobasic.

Questions?

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

Lubricant

Relieves Dry Eyes

Manufactured by :

Global Pharma Healthcare Pvt Ltd., 

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

I-DROPS ARTIFICIAL TEARS 
polyvinyl alcohol, povidone solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73921-004
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990)	POLYVINYL ALCOHOL, UNSPECIFIED	5 mg  in 1 mL
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E)	POVIDONE, UNSPECIFIED	6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73921-004-15	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(73921-004)

Revised: 2/2023

Document Id: f42b51b2-318e-eb6f-e053-2995a90a56d6

34390-5

Set id: 4a721be0-6123-4879-b428-be0a5319e68e

Version: 2

Effective Time: 20230208