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- carboxymethylcellulose sodium 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.

----------

i-Drops LUBRICANT EYE DROPS

DRUG FACTS

ACTIVE INGREDIENT

Carboxymethylcellulose Sodium 10mg in 1 ml.

PURPOSE

Eye lubricant

Uses

For use as a protectant against further irritation or to relieve dryness of the eye.

For the relief of discomfort due to minor irritations of the eye or to exposure to wind, sun or screen time.

Warnings

For external use only.

Do not use 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 accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

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

Other information

Tamper Evident. Do not use this product if neckband is missing or broken.

RETAIN THIS CARTON FOR FUTURE REFERENCE.

Store at 15°-30°C (59° to 86°F).

Inactive ingredients

Boric Acid, Potassium Chloride, Sodium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride, Sodium Hydroxide and Water for Injection.

Questions?

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

Immediate relief for dry eyes

Long lasting moisture rich formula

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 
carboxymethylcellulose sodium solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73921-002
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X)	CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73921-002-15	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(73921-002)

Revised: 2/2023

Document Id: f42b5aca-6d82-2a78-e053-2a95a90a342a

34390-5

Set id: cad56a48-05fe-449a-af63-519f073a1533

Version: 2

Effective Time: 20230208