I-DROPS ARTIFICIAL TEARS- polyvinyl alcohol 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 1.4%

PURPOSE

Eye lubricant

Uses

For use as a lubricant to prevent further irritation or to relieve dryness of the eye(s).

Warnings

• Do not use if seal on the bottle neck is broken or missing.

• Do not use if solution changes color or becomes cloudy.

• To avoid contamination, do not touch tip of container to any surface.

• Replace cap after using.

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 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].

Store away from heat.

Protect from freezing.

Keep tightly closed. RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

Benzalkonium Chloride 0.005%, Edetate Disodium, Sodium Chloride, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Purified water, Sodium Hydroxide and/or Hydrochloric Acid to adjust pH.

Questions?

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

Lubricant Eye Drops

Prevents Irritation and Relieves Dryness of the Eye

Manufactured by:

Global Pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

Eye01

I-DROPS ARTIFICIAL TEARS
polyvinyl alcohol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73921-001
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	14 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73921-001-15	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(73921-001)

Revised: 2/2023

Document Id: f42dd661-a5bd-7266-e053-2a95a90ac53b

Set id: c9892a97-5cf5-4088-8520-29c6e149cedc

Version: 2

Effective Time: 20230208

GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED