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

Eye04

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	04/01/2021	02/08/2023

Labeler - GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)

Name	Address	ID/FEI	Business Operations
Establishment
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED		860186917	manufacture(73921-004)

Revised: 2/2023

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

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

Version: 2

Effective Time: 20230208

GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED