i-Oint LUBRICANT EYE OINTMENT

i-Oint LUBRICANT EYE by

Drug Labeling and Warnings

i-Oint LUBRICANT EYE 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-OINT LUBRICANT EYE- sodium chloride ointment 
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-Oint LUBRICANT EYE OINTMENT

Drug Facts

ACTIVE INGREDIENT

Sodium chloride, 50 mg (5%)

PURPOSE

Hypertonicity agent

USES

Temporary relief of corneal edema.

WARNINGS

Do not use except under the advice and supervision of a doctor

When using this product
It may cause temporary burning and irritation
Replace cap after use
To avoid contamination do not touch tip of container to any surface.

Stop use and ask a doctor if
Condition worsens or persists for more than 72 hours.
You experience eye pain, changes in vision, continued redness or irritation of the eye

Keep out of the reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

Questions or comments?

1-800-572-6632 between 9am and 4 pm EST, Monday-Friday.

DIRECTIONS

Pull down the lower lid of the affected eye. Apply a small amount (1/4 inch) of ointment to the inside of eyelid. Apply every 3 or 4 hours or as directed by a doctor

OTHER INFORMATION

 Store at 15°-25°C (59° - 77°F)

Keep tightly closed

DO NOT FREEZE

See crimp of tube or carton for Lot Number and Expiration Date

Do not use if difficult to dispense or visible particles are seen in the product

Serious side effects associated with use of the product may be reported to the phone number below

INACTIVE INGREDIENT

Lanolin, Mineral oil, Purified water, White petrolatum

Intensive Ointment for Dry Eyes

Sterile

FOR OPHTHALMIC USE ONLY

Manufactured by :

Global Pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

I-OINT LUBRICANT EYE 
sodium chloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73921-040
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73921-040-05	1 in 1 CARTON	04/01/2021	02/08/2023
1		3.5 g in 1 TUBE; 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(73921-040)

Revised: 2/2023

Document Id: f42ac0ee-2d86-1dfb-e053-2995a90aa656

34390-5

Set id: ec7944f0-3a46-45c7-81d1-1d828e857456

Version: 2

Effective Time: 20230208