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.

----------

i-Oint LUBRICANT EYE OINTMENT

Drug Facts

ACTIVE INGREDIENTS

Mineral Oil 15%

White Petrolatum 83%

PURPOSE

Eye lubricant

USES

For use as a lubricant to prevent further irritation or to relieve dryness of the eyes.

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 lower lid of the affected eye(s) and apply small amount (one-fourth inch) of ointment to the inside of the eyelid, one or more times daily, or as directed by a doctor.

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.

See crimp for Control Number and Expiration Date.

RETAIN THIS CARTON FOR FUTURE REFERENCE.

INACTIVE INGREDIENT

Lanolin 2%

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: 73921-041
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	150 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	830 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73921-041-35	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(73921-041)

Revised: 2/2023

Document Id: f42ad3c6-61eb-93da-e053-2a95a90a9fdc

34390-5

Set id: 343eb80b-412c-45d9-8f96-57c19c3cfc9e

Version: 2

Effective Time: 20230208