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- mineral oil, white petrolatum 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

Mineral Oil 42.5%
White Petrolatum 57.3%

PURPOSE

Eye lubricant

USES

For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.
May be used as a protectant against further irritation.

WARNINGS

For external use only.
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 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 and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid.

OTHER INFORMATION

Store away from heat.

Protect from freezing.

Use only if imprinted tape seals on top and bottom flaps are intact and clearly legible.

Use before expiration date marked on container.

 Store at 59°-86°F (15°-30°C).

RETAIN THIS CARTON FOR FUTURE REFERENCE.

INACTIVE INGREDIENT

Lanolin alcohols.

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 
mineral oil, white petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73921-042
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	425 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	573 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73921-042-35	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(73921-042)

Revised: 2/2023

Document Id: f42adf39-8460-9387-e053-2995a90a06fb

34390-5

Set id: fc90fc53-dfae-46fe-a64d-3aa102c04d5e

Version: 2

Effective Time: 20230208